Topical base and active agent-containing compositions, and methods for improving and treating skin

ABSTRACT

The invention provides skin protecting and penetrating, easy-to-administer base and active agent-containing compositions, such as those including hydrocortisone, for treating the skin of mammals for different dermatologic disorders. This is effected by topically administering effective amounts of the compositions thereto in forms that address the skin and mucosa of the mouth and lips, and the rest of the body. Additionally, an optional flavoring addition to these products affords significantly better tasting, and less bitter, compositions, allowing a more pleasant experience and better compliance by patients. The compositions include a unique formulation of FANCOL VB, Natunola Castor 1023, Finsolv TN, bees wax and, optionally, one or a plurality of plant or plant seed oils, fatty alcohols, fats and flavorings, in desirable weight percents thereof, in various forms, and preferably in a form of a solid roll-on stick in a variety of sizes and of a jar or pot.

CROSS REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation-in-part application of pendingnon-provisional patent application U.S. Ser. No. 12/925,464, filed onOct. 23, 2010. This continuation-in-part patent application claims thebenefit of priority to non-provisional patent application U.S. Ser. No.12/925,464, filed on Oct. 23, 2010, which patent application is herebyincorporated into this continuation-in-part patent application in itsentirety by reference herein, including all parts thereof.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to novel topical base compositions havinga unique combination of ingredients, and weight percents thereof, foruse as effective carrier vehicles for one or a plurality of activeagents that are to be applied topically to the skin of a human being oranimal, such as hydrocortisone, in active-agent containing compositions.

The present invention also relates to novel active agent-containingcompositions, such as those that include hydrocortisone (alone or in acombination with one or more other active ingredients), or one or moreother active agents, for a topical application to the skin of a humanbeing or animal having a unique combination of ingredients, and weightpercents thereof, which have been determined to have many advantages incomparison with other topical active-agent containing compositions. Forexample, they penetrate one or more layers of, and tissues in, the skin,and have been determined to be extremely efficacious in promoting arepair, an improvement or a complete healing of a wide variety ofdifferent skin disorders, diseases and/or conditions, includinginflammation (acting as an anti-inflammatory agent), deep within thelayers and tissues of the skin, including the epidermis and epidermis.

The present invention further relates to methods for producing the aboveformulations, and methods for improving, repairing, healing or otherwisetreating the skin of a mammal with respect to a wide variety ofdifferent disorders, diseases and/or conditions, such as those that aredescribed herein, and/or causing the mammal's skin to feel soothed,softened and/or conditioned, by topically administering, or otherwiseapplying, effective amounts of the composition thereto.

2. Background

The skin of mammals, such as human beings and animals of all ages, andanimals of all types, often becomes diseased, traumatized, inflamed,reddened, injured, irritated, damaged, deteriorated, cracked, itchy,severely dried, covered with a plurality of bumps and/or blisters, acneand/or insect bites, or otherwise wounded as a result of a wide varietyof causes. These causes include, but are not limited to, physicalinjury, trauma, perforation, cutting, burning (by sun exposure, flame,hot objects and/or the like), blistering (from sun exposure, otherburning, shoes and/or the like), chapping, bites (by insects, animals,human beings and/or the like), disease or disorder (poison ivy, poisonoak, genital disease and/or the like), illness, microbes, exposure tochemicals, exposure to harsh environmental conditions (extreme hot orcold conditions, high winds, or the like), age, abuse, extreme dryness,and/or other factors.

In order to improve or promote a healing of the above (and other) typesof skin problems in both human beings and animals, it is oftennecessary, or at least desirable, to employ one or more topicalcompositions for a topical application to the skin that include one ormore active agents in a base having an ability to act as a carriervehicle for the active agents when topically applied to the skin, suchas a hydrocortisone-containing ointment or cream for topical applicationto the skin. However, very disadvantageously, many of the known topicalskin compositions that contain hydrocortisone and/or other active agentsdo not penetrate the skin, or various layers thereof, or tissues presenttherein, but in contrast, are only designed to lay on top of the skinstratum corneum (the outermost layer of the epidermis, or external skinsurface). As a result, these topical compositions often are not veryefficacious, or at all efficacious, in repairing, improving or healingone or more skin disorders, diseases or adverse conditions, such as aninflammation or redness that extends deep within the various layers of,and tissues present in, the skin.

Moreover, very disadvantageously, many of the base formulations that arepresently employed as carrier vehicles for topically applied activeagents are very greasy and messy, often soiling the clothing of theuser, are not convenient for use by consumers and/or are subject todeterioration under one or more adverse environmental conditions (i.e.,they deteriorate), such as high temperatures. For example, the baseformulations that are employed in some of the known andcommercially-available rigid stick formulations for a topicalapplication to the skin and/or lips crack in relatively coldtemperatures and/or melt in relatively high temperatures, causing theproduct to become less useful or completely useless, and often extremelymessy and a waste of money. Because many of these products include highquantities of “oily” and/or “fatty” types of substances, if suchsubstances melt under conditions of relatively high heat, such as whenthey are left in a glove box of a vehicle during hot summer months, theoils and/or fats, which generally are not soluble in water or inaqueous-based cleaning agents, can be extremely difficult to remove frompapers, clothing and similar types of items, upon which they may meltand/or spill when melted.

Moreover, most existing topical skin compositions have either a verythick feel, lacking cosmetic elegance and therefore decreasingcompliance, or a thin feel, which may increase compliance, but decreasesefficacy greatly because an ability to decrease transepidermal waterloss (TEWL) is very important for any of these medications, and is oftenlacking therefrom.

There are very few, if any, topical skin medications includinghydrocortisone (and/or other active ingredients) on the market that arepresent in a solid form, such as a stick, allowing a user to treat anarea of skin disease that is very small, such as a size of a pinpoint,or very large, such as a plurality of square inches in diameter, andeffectively seal the skin off from further damage, all the whiledecreasing transepidermal water loss (TEWL) and repairing or fullyhealing the skin. Additionally, those topical skin medications thatinclude hydrocortisone usually have an undesirable “‘tacky” feel tothem, and have a very bitter taste and odor if applied to the mucosalareas of the lips, which is also very undesirable, and renders theirefficacy less likely due to poor patient compliance. To date, none ofthe existing hydrocortisone balm lip formulations appear to have solvedthis problem of having a bitter taste. Additionally, none of theseformulations have a relatively solid consistency, leaving them unlikelyto repair, improve or heal the skin of a patient for long periods oftime, as they come off of the skin easily.

Furthermore, none of the topical skin preparations includinghydrocortisone in a stick formulation that are on the market have thedirective of having one or two types of methods and/or sizes to apply toeither large or small surfaces of the skin. For this reason, they areseverely limited when it comes to the uses and applicability overvarious body surface areas. For example, if one likens this to anotherprocess, if one only had one size of a paint brush that was no largerthan a toothbrush in size, the paint brush would limit the uses of thisproduct. Interestingly, while hydrocortisone has been available for manyyears, and other formulations have attempted to apply it as a cream tothe body, or even as an ointment, there have been nocommercially-available products that combine a palatable and elegantform of it in a lip-based product as well as in a product that issuitable for larger body surfaces. None of the existing formulationsappear to have a large body application methodology, as they only have a‘lip balm’ size. They are not indicated for the body, and there is noinducement on any packaging or promotional material for the finger orhand cracks that occur in the drier times of the year or with variousskin diseases.

Additionally, the topical skin products including hydrocortisone thathave been marketed for over-the-counter treatments have typically beenvery limited as to treatment of significant skin disease, as they havebeen creams or ointments. These preparations typically have lesspenetration and less efficacy on adverse skin conditions, such aspsoriasis and eczema, and therefore, generally have little or no healingor other effect on the skin of the majority of patients. As a result,none of these existing hydrocortisone products have any indication ofusage for skin diseases other than chapped lips generally or chappedlips in patients with psoriasis or who are taking Accutane or Soriatane(i.e., drugs that cause chapped lips), or related efficacy.

In view of the above, it would be extremely beneficial to provide, andtreat the skin of mammals having one or a plurality of skin conditions,disorders, diseases and/or the like, with a topical composition forapplication to the skin including one or more active agents, such ashydrocortisone, that: (i) penetrates one or a plurality of layers of themammal's skin, including the epidermis and dermis, and the tissuestherein, thereby exhibiting efficacious repair, complete healing and/orother beneficial actions in connection with a variety of different skinproblems, such as eczema, psoriasis, dermatitis, seborrheic dermatitisor severe dryness, deep within the layers and/or tissues of the skin(rather than only resting on top of the outside of the outermost layerof the mammal's skin); (ii) has an ability to decrease or preventtransepidermal water loss (TEWL) from the skin and effectively partiallyor fully seal the skin off from further environmental and/or otherdamage; (iii) does not have an undesirable feel to the touch or skin ofa mammal, such as a very thick, very thin or tacky (sticky) feel, butrather has a relatively smooth, non-tacky, non-sticky and desirablefeel; (iv) has a pleasant or desirable taste and odor to a user whenapplied to mucosal areas of the lips (or elsewhere); (v) may be formedinto a wide variety of sizes and/or shapes, or in multiple sizes and/orshapes, (vi) may be applied as a product over various different bodysurface areas of different sizes and/or types, such as a lip-basedproduct for application to the lips and also as separate products thatare suitable for topical application to larger body surfaces and, thus,permit a user to treat very small and/or very large areas of the skin(such as a pinpoint area and/or an area spanning one or a plurality ofsquare inches or other shapes); (vii) is convenient and easy toadminister for users; (viii) is safe and reliable for use by mammals;(ix) maintains its consistency, form and shape under relatively extremeenvironmental conditions, such as at relatively low temperatures, forexample, on a ski slope, and at relatively high temperatures, forexample, in a hot vehicle during the summer months; (x) is cosmeticallyelegant and physically appealing and desirable; (xi) promotes orotherwise enhances patient compliance; and (xii) is relativelyinexpensive.

It would also be extremely beneficial to provide base compositions thathave the above characteristics, and can properly function as carriervehicles for one or more active agents to be applied topically to theskin of a human being or animal.

Description of Related Art

According to a Burt's Bees lip balm Internet web site, Burt's Bees lipbalm, which is present in a tube, contains beeswax, cocos nucifera(coconut) oil, helianthus annuus (sunflower) seed oil, mentha piperita(peppermint) oil, lanolin, tocopherol, rosmarinus officinalis (rosemary)leaf extract, glycine soja (soybean) oil, canola oil, Tin: cera alba(beeswax, cire d'abeille), prunus amygdalus dulcis (sweet almond) oil,mentha piperita (peppermint) oil, lanolin, tocopherol, rosmarinusofficinalis (rosemary) leaf extract, glycine soja (soybean) oil andcanola oil (huile de colza).

According to a ChapStick® web site, ChapStick® contains seven naturalingredients that function as skin-conditioning agents or moisturizers,which remain on the surface of the skin. Some of these ingredients arealso stated to prevent evaporation of water and protect lips from dryingand chapping when exposed to wind or cold weather. The process ofmanufacturing ChapStick® is stated to be similar to following a recipe.A big blender is stated to mix the heated ingredients of ChapStick®. Thecolor and flavor are added, and then the warm mixture is poured intocontainers.

Carmex is a brand of topical lip balm that is meant to improve oreliminate cold sores and soothe dry or chapped lips. It may be sold injars, sticks and squeezable tubes. According to a Carmex Internet website, traditional Carmex contains camphor, menthol, phenol, beeswax,cetyl esters, flavor, fragrance, lanolin, paraffin, petrolatum,salicylic acid and theobroma cacao(cocoa) seed butter.

According to a Blistex Internet web site, Blistex medicated lip balm (inthe form of a hard stick), contains the active ingredients dimethicone(2.0%) (skin protectant), oxybenzone (2.5%) (sunscreen) and padimate O(6.6%) (sunscreen), as well as the other ingredients bees wax, camphor,cetyl alcohol, cetyl Palmitate, euphorbia cerifera (candelilla) wax,flavors, isopropyl Myristate, isopropyl Palmitate, isopropyl stearate,lanolin, lanolin oil, menthol, methylparaben, mineral oil, ozokerite,paraffin, petrolatum, polybutene, propylparaben, red 6 lake, theobromacacao (cocoa) seed butter and titanium dioxide.

U.S. Pat. No. 5,662,993 describes stick formulations for topicaldelivery of water soluble and/or water insoluble agents, which maycontain steroids, antibiotics, antifungals, antihistamines antiinflammatories or local anesthetics. The vehicles comprise a combinationof waxes and oils and a surfactant in embodiments involving watersoluble agents.

U.S. Pat. No. 6,228,351 describes a lip balm for treating cheilitis(painful dry inflamed lips) containing from 0.2% to 2.5% hydrocortisonein a base of beeswax mineral oil and petroleum jelly, wherein the amountof petroleum jelly is not more than that of the beeswax and mineral oilcombined, and the amount of mineral oil is roughly equal to the amountof beeswax. In contrast with the compositions and base formulations ofthe present invention, the lip balms described by the '351 patent, whichcontain many different ingredients, and weight percents thereof, such aslarge quantities of petroleum jelly (from 40% to 50% by weight of thebase), are used only upon the lips, and disadvantageously have anundesirable taste, which is typical of hydrocortisone-containingproducts (and tends to discourage, reduce or eliminate patientcompliance). Further, as a result of its different ingredients,particularly the large amount of petroleum jelly, these lip balms have avery different consistency in comparison with thehydrocortisone-containing (and other) compositions of the presentinvention. They have a liquid or semi-liquid type of a feel to the touch(i.e., not a solid feel), and may be messy and/or sloppy for use byindividuals, and to their clothing, jewelry and surrounding objects(papers, books, maps, sunglasses, seat or car and/or the like),particularly when present at high temperatures. Further, these lip balmsare not indicated by the '351 patent for any skin malady or conditionother than psoriasis, and have not been shown by the '351 patent to beefficacious for any such malady or condition.

Published U.S. Patent Application No. US 2004/0091539 A1 describes asolid stick topical composition containing a corticosteroid, petrolatum,wax, propyleneglycol and an emulsifier.

Published U.S. Patent Application No. US 2003/0232091 A1 describes acontrolled release system for stabilizing retinol, retinol derivatives,and extracts containing retinol in cosmetic, dermatological, andpharmaceutical compositions.

Published U.S. Patent Application No. US 2004/0202725 A1 describescompositions for the treatment of pilosebaceous gland inflammations,especially of the hair follicle and its appendages, in particular ofAcne Vulgaris and Folliculitis, comprising as active ingredient aluminumfluoride, or chemical compounds that finally release aluminum fluoride.

None of the patent documents or web sites that are identified abovedescribe or suggest the unique base and active agent-containingformulations of the present invention, or the related production orapplication methods, or compositions having the advantages that aredescribed herein.

SUMMARY OF THE INVENTION

It has been surprisingly and unexpectedly determined after a significantamount of experimentation and testing on human beings that base andactive-agent containing compositions having the unique formulations thatare described herein (i.e., a particular combination of ingredients, andparticular weight percents thereof), when topically applied to the skinof a mammal, very advantageously: (i) penetrate one or a plurality oflayers of the mammal's skin, including the epidermis and dermis, and thetissues therein, thereby exhibiting efficacious repair, complete healingand/or other beneficial actions in connection with a variety ofdifferent skin problems, such as eczema, psoriasis, dermatitis,seborrheic dermatitis, cracks, cuts, wounds, punctures, bumps, rashes,inflammation, severe dryness and the like, deep within the layers and/ortissues of the skin (rather than only resting on top of the outside ofthe outermost layer of the mammal's skin); (ii) have an ability todecrease or prevent transepidermal water loss (TEWL) from the skin andeffectively partially or fully seal the skin off from furtherenvironmental and/or other damage; (iii) do not have an undesirable feelto the touch or skin of a mammal, such as a very thick, very thin ortacky (sticky) feel, but rather have a relatively smooth, non-tacky,non-sticky and desirable feel; (iv) have a pleasant or desirable tasteand odor to a user when applied to mucosal areas of the lips (orelsewhere), or have no, or a minimal, bitter or other undesirable tasteand/or odor (whether including one or more flavoring ingredients ornot); (v) may be formed into a wide variety of sizes and/or shapes, orin multiple sizes and/or shapes, in a wide variety of differentcontainers, such as non-squeezable or squeezable tubes, spray ornon-spray cans, jars, pots, and the like; (vi) may be applied as aproduct over various different body surface areas of different sizesand/or types, such as a lip-based product for application to the lips,and also as separate products that are suitable for topical applicationto larger body surfaces and, thus, permit a user to treat very smalland/or very large areas of the skin (such as a pinpoint area and/or anarea spanning one or a plurality of square inches or other shapes);(vii) are convenient and easy to administer for users; (viii) are safeand reliable for users; (ix) maintain their consistency, form and shapeunder relatively extreme environmental conditions, such as at relativelylow temperatures, for example, on a ski slope, and at relatively hightemperatures, for example, in a hot vehicle during the summer months;(x) are cosmetically elegant and physically appealing and desirable;(xi) promote or otherwise enhances or encourages patient or usercompliance; and/or (xii) are relatively inexpensive. Topical base andactive agent-containing compositions within the present inventiontypically include each of the above benefits, and are improvements overknown topical base and active agent-containing compositions, includingthose containing hydrocortisone.

When employed in the manner, and under the conditions, that aredescribed herein, the base and active agent-containing compositions ofthe invention, which have specific formulations including a uniquecombination of ingredients, and weight percents thereof, havesurprisingly and unexpectedly been determined via a significant amountof experimentation and testing on human beings to function extremelywell together, providing topical skin compositions that are extremelyefficacious for: (i) repairing, improving, partially or fully healing,or otherwise treating *a wide variety of different skin disorders,diseases, conditions, maladies, dryness and/or the like, of the skin ofmammals, such as inflammation, redness, itching, bumps, blisters, cuts,punctures, other wounds, cracking, severe dryness, allergic reactions,insect bites, trauma, irritant dermatitis, contact dermatitis,seborrheic dermatitis, stasis dermatitis, perleche, psoriasis, eczema,eczema craquele, acne excoriee (a form or irritated and/or picked acne),allergies, other skin irritations, a variety of different skincomplications resulting from acne, xerosis, disease related skinconditions and dryness from medications, such as isotretinoin,acitretin, lipid-lowering agents and/or the like; and/or (ii) causingthe skin of a mammal to feel less painful, less irritated, less itchy,softened, soothed and/or conditioned, often with a 100% improvement, asis described in the experiments that are described herein. Thehydrocortisone-containing skin balms of the present invention have beensignificantly tested experimentally with human beings and determined tobe very effective, for example, on hand dermatitis, eczema, seborrheicdermatitis, cracks, cuts, punctures and severe dryness from lipconditions due to accutane usage, as is illustrated in the drawingsincluded herein (FIGS. 2-17).

The base and active agent-containing compositions of the presentinvention exhibit benefits that are described above, and otherwiseherein, generally to a significantly or far greater extent (for example,on a sale of from about 0% to about 100%) in comparison with other baseor active agent-containing compositions, and typically do not exhibitany of the disadvantages that are discussed hereinabove in theBackground of Invention section. Many other such compositions do notexhibit one or more of the above advantages at all, or to anysignificant extent. Thus, the base and active agent-containingcompositions of the present invention are superior to, and a significantimprovement of such compositions and base formulations as a result oftheir numerous benefits and advantages, and a significant advance inthis art. They have advantages that overcome many or all of theshortcomings that are described herein of other topical skin base andactive agent containing compositions, and are able to repair, improveand/or heal patients (or other users) having one or more of the variousadverse skin conditions, disorders or diseases that are describedherein, as well as many others.

The base and active agent-containing compositions of the invention arevery different from any existing topical lip or skin balm (or othercomposition) because they include a unique combination of theingredients Finsolv TN, Natunola Castor 1023, FANCOL VB and bees wax, aswell as one or more optional ingredients, which together produce apreferably solid, firm, yet pliable, balm that has an ability tomaintain its consistency, form and shape over time, and reduces, masksor eliminates the taste(s) and odor(s) of otherwise undesirably tastingingredients, for example, the undesirable bitter taste ofhydrocortisone.

Base

In one aspect, the present invention provides a topical base compositionin a solid or semi-solid form for use as a carrier vehicle for one or aplurality of active agents, such as hydrocortisone, comprising FANCOLVB, Natunola Castor 1023, Finsolv TN and bees wax, each in amounts thatare effective for collectively forming together a base composition in asold or semi-solid form having an ability to function effectively as atopically-applied carrier vehicle for the active agents.

In another aspect, the present invention provides a topical basecomposition in a solid or semi-solid form for use as a carrier vehiclefor one or a plurality of active agents, such as hydrocortisone,consisting of (or consisting essentially of) FANCOL VB, Natunola Castor1023, Finsolv TN and bees wax, each in amounts that are effective forcollectively forming together a base composition in a sold or semi-solidform having an ability to function effectively as a topically-appliedcarrier vehicle for the active agents.

In another aspect, the present invention provides a topical basecomposition in a solid or semi-solid form for use as a carrier vehiclefor one or a plurality of active agents, such as hydrocortisone,comprising FANCOL VB, Natunola Castor 1023, Finsolv TN, bees wax, one ora plurality of plant or plant seed oils, one or a plurality of fattyalcohols, and one or a plurality of fats, each in combined amounts thatare effective for collectively forming together a base composition in asold or semi-solid form having an ability to function effectively as atopically-applied carrier vehicle for the active agents.

In still another aspect, the present invention provides a topical basecomposition in a solid or semi-solid form for use as a carrier vehiclefor one or a plurality of active agents, such as hydrocortisone,consisting of (or consisting essentially of) FANCOL VB, Natunola Castor1023, Finsolv TN, bees wax, one or a plurality of plant or plant seedoils, one or a plurality of fatty alcohols, and one or a plurality offats, each in combined amounts that are effective for collectivelyforming together a base composition in a sold or semi-solid form havingan ability to function effectively as a topically-applied carriervehicle for the active agents.

In another aspect, the present invention provides a topical basecomposition in a solid or semi-solid form for use as a carrier vehiclefor one or a plurality of active agents, such as hydrocortisone,comprising FANCOL VB, Natunola Castor 1023, Finsolv TN, bees wax, one ora plurality of plant or plant seed oils, one or a plurality of fattyalcohols, one or a plurality of fats, and one or a plurality offlavorings, each in combined amounts that are effective for collectivelyforming together a base composition in a sold or semi-solid form havingan ability to function effectively as a topically-applied carriervehicle for the active agents, and wherein the base composition does nothave a bitter taste or odor, has no distinctive taste or odor or has apleasant taste or odor, or both (even in the absence of any flavoring).

In yet another aspect, the present invention provides a topical basecomposition in a solid or semi-solid form for use as a carrier vehiclefor one or a plurality of active agents, such as hydrocortisone,consisting of (or consisting essentially of) FANCOL VB, Natunola Castor1023, Finsolv TN, bees wax, one or a plurality of plant or plant seedoils, one or a plurality of fatty alcohols, one or a plurality of fats,and one or a plurality of flavorings, each in combined amounts that areeffective for collectively forming together a base composition in a soldor semi-solid form having an ability to function effectively as atopically-applied carrier vehicle for the active agents, and wherein thebase composition does not have a bitter taste or odor, has nodistinctive taste or odor or has a pleasant taste or odor, or both (evenin the absence of any flavoring).

Original (Specific) Formulations

In another aspect, the present invention provides a topical basecomposition in a solid or semi-solid form for use as a carrier vehiclefor one or a plurality of active agents, such as hydrocortisone,comprising:

-   -   (a) FANCOL VB, wherein the FANCOL VB is present in the base        composition in an amount ranging from about 9 to about 25 weight        percent;    -   (b) Natunola Castor 1023, wherein the Natunola Castor 1023 is        present in the base composition in an amount ranging from about        16 to about 39 weight percent;    -   (c) Finsolv TN, wherein the Finsolv TN is present in the base        composition in an amount ranging from about 9 to about 25 weight        percent;    -   (d) bees wax, wherein the bees wax is present in the base        composition in an amount ranging from about 18 to about 43        weight percent;    -   (e) optionally, one or a plurality of plant oils or plant seed        oils, wherein the plant or plant seed oils are present in the        base composition in a combined amount ranging from about 0 to        about 24 weight percent;    -   (f) optionally, one or a plurality of fatty alcohols, wherein        the fatty alcohols are present in the base composition in a        combined amount ranging from about 0 to about 22 weight percent;    -   (g) optionally, one or a plurality of fats, wherein the fats are        present in the base composition in a combined amount ranging        from about 0 to about 9 weight percent; and    -   (h) optionally, one or a plurality of flavorings, wherein the        flavorings are present in the base composition in a combined        amount ranging from about 0 to about 3.5 weight percent;        wherein the base composition is in a sold or semi-solid form        having an ability to function effectively as a topically-applied        carrier vehicle for the active agents.

In still another aspect, the present invention provides a topical basecomposition in a solid or semi-solid form for use as a carrier vehiclefor one or a plurality of active agents, such as hydrocortisone,consisting of (or consisting essentially of):

-   -   (a) FANCOL VB, wherein the FANCOL VB is present in the base        composition in an amount ranging from about 9 to about 25 weight        percent;    -   (b) Natunola Castor 1023, wherein the Natunola Castor 1023 is        present in the base composition in an amount ranging from about        16 to about 39 weight percent;    -   (c) Finsolv TN, wherein the Finsolv TN is present in the base        composition in an amount ranging from about 9 to about 25 weight        percent;    -   (d) bees wax, wherein the bees wax is present in the base        composition in an amount ranging from about 18 to about 43        weight percent;    -   (e) optionally, one or a plurality of plant oils or plant seed        oils, wherein the plant or plant seed oils are present in the        base composition in a combined amount ranging from about 0 to        about 24 weight percent;    -   (f) optionally, one or a plurality of fatty alcohols, wherein        the fatty alcohols are present in the base composition in a        combined amount ranging from about 0 to about 22 weight percent;    -   (g) optionally, one or a plurality of fats, wherein the fats are        present in the base composition in a combined amount ranging        from about 0 to about 9 weight percent; and    -   (h) optionally, one or a plurality of flavorings, wherein the        flavorings are present in the base composition in a combined        amount ranging from about 0 to about 3.5 weight percent;        wherein the base composition is in a sold or semi-solid form        having an ability to function effectively as a topically-applied        carrier vehicle for the active agents.

In another aspect, the present invention provides a topical basecomposition in a solid or semi-solid form for use as a carrier vehiclefor one or a plurality of active agents, such as hydrocortisone,comprising:

-   -   (a) FANCOL VB, wherein the FANCOL VB is present in the base        composition in an amount ranging from about 9 to about 13 weight        percent;    -   (b) Natunola Castor 1023, wherein the Natunola Castor 1023 is        present in the base composition in an amount ranging from about        16 to about 20 weight percent;    -   (c) Finsolv TN, wherein the Finsolv TN is present in the base        composition in an amount ranging from about 9 to about 13 weight        percent;    -   (d) bees wax, wherein the bees wax is present in the base        composition in an amount ranging from about 18 to about 22        weight percent;    -   (e) one or more plant or plant seed oils, wherein the plant or        plant seed oils are present in the base composition in a        combined amount ranging from about 0.1 to about 24 weight        percent;    -   (f) one or more fatty alcohols, wherein the fatty alcohols are        present in the base composition in a combined amount ranging        from about 0.1 to about 22 weight percent;    -   (g) one or more fats, wherein the fats are present in the base        composition in a combined amount ranging from about 0.1 to about        9 weight percent; and    -   (h) optionally, one or a plurality of flavorings, wherein the        flavorings are present in the base composition in an amount        ranging from about 0 to about 3.5 weight percent;        wherein the base composition is in a sold or semi-solid form        having an ability to function effectively as a topically-applied        carrier vehicle for the active agents.

In still another aspect, the present invention provides a topical basecomposition in a solid or semi-solid form for use as a carrier vehiclefor one or a plurality of active agents, such as hydrocortisone,consisting of (or consisting essentially of):

-   -   (a) FANCOL VB, wherein the FANCOL VB is present in the base        composition in an amount ranging from about 9 to about 13 weight        percent;    -   (b) Natunola Castor 1023, wherein the Natunola Castor 1023 is        present in the base composition in an amount ranging from about        16 to about 20 weight percent;    -   (c) Finsolv TN, wherein the Finsolv TN is present in the base        composition in an amount ranging from about 9 to about 13 weight        percent;    -   (d) bees wax, wherein the bees wax is present in the base        composition in an amount ranging from about 18 to about 22        weight percent;    -   (e) one or more plant or plant seed oils, wherein the plant or        plant seed oils are present in the base composition in a        combined amount ranging from about 0.1 to about 24 weight        percent;    -   (f) one or more fatty alcohols, wherein the fatty alcohols are        present in the base composition in a combined amount ranging        from about 0.1 to about 22 weight percent;    -   (g) one or more fats, wherein the fats are present in the base        composition in a combined amount ranging from about 0.1 to about        9 weight percent; and    -   (h) optionally, one or a plurality of flavorings, wherein the        flavorings are present in the base composition in an amount        ranging from about 0 to about 3.5 weight percent;        wherein the base composition is in a sold or semi-solid form        having an ability to function effectively as a topically-applied        carrier vehicle for the active agents.

Subsequent (Improved) Formulations

In another aspect, the present invention provides a topical basecomposition in a solid or semi-solid form for use as a carrier vehiclefor one or a plurality of active agents, such as hydrocortisone,comprising:

-   -   (a) FANCOL VB, wherein the FANCOL VB is present in the base        composition in an amount ranging from about 6 to about 25 weight        percent;    -   (b) Natunola Castor 1023, wherein the Natunola Castor 1023 is        present in the base composition in an amount ranging from about        5 to about 39 weight percent;    -   (c) Finsolv TN, wherein the Finsolv TN is present in the base        composition in an amount ranging from about 9 to about 25 weight        percent;    -   (d) bees wax, wherein the bees wax is present in the base        composition in an amount ranging from about 6 to about 43 weight        percent;    -   (e) optionally, one or a plurality of plant oils or plant seed        oils, wherein the plant or plant seed oils are present in the        base composition in a combined amount ranging from about 0 to        about 38.5 (38.0 if one or more flavoring ingredients are        present) weight percent;    -   (f) optionally, one or a plurality of fatty alcohols, wherein        the fatty alcohols are present in the base composition in a        combined amount ranging from about 0 to about 25 weight percent;    -   (g) optionally, one or a plurality of fats, wherein the fats are        present in the base composition in a combined amount ranging        from about 0 to about 12 weight percent; and    -   (h) optionally, one or a plurality of flavorings, wherein the        flavorings are present in the base composition in a combined        amount ranging from about 0 to about 3.5 weight percent;        wherein the base composition is in a sold or semi-solid form        having an ability to function effectively as a topically-applied        carrier vehicle for the active agents.

In still another aspect, the present invention provides a topical basecomposition in a solid or semi-solid form for use as a carrier vehiclefor one or a plurality of active agents, such as hydrocortisone,consisting of (or consisting essentially of):

-   -   (a) FANCOL VB, wherein the FANCOL VB is present in the base        composition in an amount ranging from about 6 to about 25 weight        percent;    -   (b) Natunola Castor 1023, wherein the Natunola Castor 1023 is        present in the base composition in an amount ranging from about        5 to about 39 weight percent;    -   (c) Finsolv TN, wherein the Finsolv TN is present in the base        composition in an amount ranging from about 9 to about 25 weight        percent;    -   (d) bees wax, wherein the bees wax is present in the base        composition in an amount ranging from about 6 to about 43 weight        percent;    -   (e) optionally, one or a plurality of plant oils or plant seed        oils, wherein the plant or plant seed oils are present in the        base composition in a combined amount ranging from about 0 to        about 38.5 (38.0 if one or more flavoring ingredients are        present) weight percent;    -   (f) optionally, one or a plurality of fatty alcohols, wherein        the fatty alcohols are present in the base composition in a        combined amount ranging from about 0 to about 25 weight percent;    -   (g) optionally, one or a plurality of fats, wherein the fats are        present in the base composition in a combined amount ranging        from about 0 to about 12 weight percent; and    -   (h) optionally, one or a plurality of flavorings, wherein the        flavorings are present in the base composition in a combined        amount ranging from about 0 to about 3.5 weight percent;        wherein the base composition is in a sold or semi-solid form        having an ability to function effectively as a topically-applied        carrier vehicle for the active agents.

Preferred subsequent (improved) base compositions of the inventioninclude those that are described below.

Non-Flavored Base Compositions (Non-OTC and No Flavoring Ingredients)

In another aspect, the present invention provides a topical basecomposition in a solid or semi-solid form for use as a carrier vehiclefor one or a plurality of active agents, such as hydrocortisone,comprising:

-   -   (a) FANCOL VB, wherein the FANCOL VB is present in the base        composition in an amount ranging from about 6 to about 16 weight        percent;    -   (b) Natunola Castor 1023, wherein the Natunola Castor 1023 is        present in the base composition in an amount ranging from about        5 to about 15 weight percent;    -   (c) Finsolv TN, wherein the Finsolv TN is present in the base        composition in an amount ranging from about 10 to about 20        weight percent;    -   (d) bees wax, wherein the bees wax is present in the base        composition in an amount ranging from about 6 to about 16 weight        percent;    -   (e) one or a plurality of plant oils or plant seed oils, wherein        the plant or plant seed oils are present in the base composition        in a combined amount ranging from about 13.5 to about 38.5        weight percent;    -   (f) one or a plurality of fatty alcohols, wherein the fatty        alcohols are present in the base composition in a combined        amount ranging from about 15 to about 25 weight percent; and    -   (g) one or a plurality of fats, wherein the fats are present in        the base composition in a combined amount ranging from about 2        to about 12 weight percent;        wherein the base composition is in a sold or semi-solid form        having an ability to function effectively as a topically-applied        carrier vehicle for the active agents.

In still another aspect, the present invention provides a topical basecomposition in a solid or semi-solid form for use as a carrier vehiclefor one or a plurality of active agents, such as hydrocortisone,consisting of (or consisting essentially of):

-   -   (a) FANCOL VB, wherein the FANCOL VB is present in the base        composition in an amount ranging from about 6 to about 16 weight        percent;    -   (b) Natunola Castor 1023, wherein the Natunola Castor 1023 is        present in the base composition in an amount ranging from about        5 to about 15 weight percent;    -   (c) Finsolv TN, wherein the Finsolv TN is present in the base        composition in an amount ranging from about 10 to about 20        weight percent;    -   (d) bees wax, wherein the bees wax is present in the base        composition in an amount ranging from about 6 to about 16 weight        percent;    -   (e) one or a plurality of plant oils or plant seed oils, wherein        the plant or plant seed oils are present in the base composition        in a combined amount ranging from about 13.5 to about 38.5        weight percent;    -   (f) one or a plurality of fatty alcohols, wherein the fatty        alcohols are present in the base composition in a combined        amount ranging from about 15 to about 25 weight percent; and    -   (g) one or a plurality of fats, wherein the fats are present in        the base composition in a combined amount ranging from about 2        to about 12 weight percent;        wherein the base composition is in a sold or semi-solid form        having an ability to function effectively as a topically-applied        carrier vehicle for the active agents.

Flavored Base Compositions (Non-OTC, but Including FlavoringIngredient(s))

In another aspect, the present invention provides a topical basecomposition in a solid or semi-solid form for use as a carrier vehiclefor one or a plurality of active agents, such as hydrocortisone,comprising:

-   -   (a) FANCOL VB, wherein the FANCOL VB is present in the base        composition in an amount ranging from about 6 to about 16 weight        percent;    -   (b) Natunola Castor 1023, wherein the Natunola Castor 1023 is        present in the base composition in an amount ranging from about        5 to about 15 weight percent;    -   (c) Finsolv TN, wherein the Finsolv TN is present in the base        composition in an amount ranging from about 10 to about 20        weight percent;    -   (d) bees wax, wherein the bees wax is present in the base        composition in an amount ranging from about 6 to about 16 weight        percent;    -   (e) one or a plurality of plant oils or plant seed oils, wherein        the plant or plant seed oils are present in the base composition        in a combined amount ranging from about 13.0 to about 38.0        weight percent;    -   (f) one or a plurality of fatty alcohols, wherein the fatty        alcohols are present in the base composition in a combined        amount ranging from about 15 to about 25 weight percent;    -   (g) one or a plurality of fats, wherein the fats are present in        the base composition in a combined amount ranging from about 2        to about 12 weight percent; and    -   (h) one or a plurality of flavorings, wherein the flavorings are        present in the base composition in a combined amount ranging        from about 0.1 to about 2.5 weight percent;        wherein the base composition is in a sold or semi-solid form        having an ability to function effectively as a topically-applied        carrier vehicle for the active agents.

In another aspect, the present invention provides a topical basecomposition in a solid or semi-solid form for use as a carrier vehiclefor one or a plurality of active agents, such as hydrocortisone,consisting of (or consisting essentially of):

-   -   (a) FANCOL VB, wherein the FANCOL VB is present in the base        composition in an amount ranging from about 6 to about 16 weight        percent;    -   (b) Natunola Castor 1023, wherein the Natunola Castor 1023 is        present in the base composition in an amount ranging from about        5 to about 15 weight percent;    -   (c) Finsolv TN, wherein the Finsolv TN is present in the base        composition in an amount ranging from about 10 to about 20        weight percent;    -   (d) bees wax, wherein the bees wax is present in the base        composition in an amount ranging from about 6 to about 16 weight        percent;    -   (e) one or a plurality of plant oils or plant seed oils, wherein        the plant or plant seed oils are present in the base composition        in a combined amount ranging from about 13.0 to about 38.0        weight percent;    -   (f) one or a plurality of fatty alcohols, wherein the fatty        alcohols are present in the base composition in a combined        amount ranging from about 15 to about 25 weight percent;    -   (g) one or a plurality of fats, wherein the fats are present in        the base composition in a combined amount ranging from about 2        to about 12 weight percent; and    -   (h) one or a plurality of flavorings, wherein the flavorings are        present in the base composition in a combined amount ranging        from about 0.1 to about 2.5 weight percent;        wherein the base composition is in a sold or semi-solid form        having an ability to function effectively as a topically-applied        carrier vehicle for the active agents.

Active Agent Containing Composition

In another aspect, the present invention provides a composition fortopical application to the skin of a mammal for repairing, improving orfully healing a skin disorder, disease or condition, or for causing themammal's skin to experience a reduction in pain, soreness or itchiness,or an increase in soothing, softening or conditioning, or a combinationthereof, comprising:

-   -   (a) one or a plurality of active agents, such as hydrocortisone,        wherein the active agents are present in the composition in a        combined amount that is effective for repairing, improving or        healing the mammal's skin, or causing the mammal's skin to        experience a reduction in pain, soreness or itchiness, or an        increase in soothing, softening or conditioning, or a        combination thereof, after a topical application of the        composition to the mammal's skin; and    -   (b) a base composition, wherein the base composition is present        in the composition in an amount that is effective for permitting        the base composition to function effectively as a carrier        vehicle for the active agents when topically applied to the        mammal's skin, and wherein the base composition includes FANCOL        VB, Natunola Castor 1023, Finsolv TN and bees wax, each in        amounts that are effective for collectively forming together the        base composition in a sold or semi-solid form.

In yet another aspect, the present invention provides a composition fortopical application to the skin of a mammal for repairing, improving orfully healing a skin disorder, disease or condition, or for causing themammal's skin to experience a reduction in pain, soreness or itchiness,or an increase in soothing, softening or conditioning, or a combinationthereof, consisting of (or consisting essentially of):

-   -   (a) one or a plurality of active agents, such as hydrocortisone,        wherein the active agents are present in the composition in a        combined amount that is effective for repairing, improving or        healing the mammal's skin, or causing the mammal's skin to        experience a reduction in pain, soreness or itchiness, or an        increase in soothing, softening or conditioning, or a        combination thereof, after a topical application of the        composition to the mammal's skin; and    -   (b) a base composition, wherein the base composition is present        in the composition in an amount that is effective for permitting        the base composition to function effectively as a carrier        vehicle for the active agents when topically applied to the        mammal's skin, and wherein the base composition includes FANCOL        VB, Natunola Castor 1023, Finsolv TN and bees wax, each in        amounts that are effective for collectively forming together the        base composition in a sold or semi-solid form.

In another aspect, the present invention provides a composition fortopical application to the skin of a mammal for repairing, improving orfully healing a skin disorder, disease or condition, or for causing themammal's skin to experience a reduction in pain, soreness or itchiness,or an increase in soothing, softening or conditioning, or a combinationthereof, comprising:

-   -   (a) one or a plurality of active agents, such as hydrocortisone,        wherein the active agents are present in the composition in a        combined amount that is effective for repairing, improving or        healing the mammal's skin, or causing the mammal's skin to        experience a reduction in pain, soreness or itchiness, or an        increase in soothing, softening or conditioning, or a        combination thereof, after a topical application of the        composition to the mammal's skin; and    -   (b) a base composition, wherein the base composition is present        in the composition in an amount that is effective for permitting        the base composition to function effectively as a carrier        vehicle for the active agents when topically applied to the        mammal's skin, and wherein the base composition includes FANCOL        VB, Natunola Castor 1023, Finsolv TN, bees wax, one or a        plurality of plant or plant seed oils, one or a plurality of        fatty alcohols, and one or a plurality of fats, each in combined        amounts that are effective for collectively forming together a        base composition in a sold or semi-solid form.

In still another aspect, the present invention provides a compositionfor topical application to the skin of a mammal for repairing, improvingor fully healing a skin disorder, disease or condition, or for causingthe mammal's skin to experience a reduction in pain, soreness oritchiness, or an increase in soothing, softening or conditioning, or acombination thereof, consisting of (or consisting essentially of):

-   -   (a) one or a plurality of active agents, such as hydrocortisone,        wherein the active agents are present in the composition in a        combined amount that is effective for repairing, improving or        healing the mammal's skin, or causing the mammal's skin to        experience a reduction in pain, soreness or itchiness, or an        increase in soothing, softening or conditioning, or a        combination thereof, after a topical application of the        composition to the mammal's skin; and    -   (b) a base composition, wherein the base composition is present        in the composition in an amount that is effective for permitting        the base composition to function effectively as a carrier        vehicle for the active agents when topically applied to the        mammal's skin, and wherein the base composition includes FANCOL        VB, Natunola Castor 1023, Finsolv TN, bees wax, one or a        plurality of plant or plant seed oils, one or a plurality of        fatty alcohols, and one or a plurality of fats, each in combined        amounts that are effective for collectively forming together a        base composition in a sold or semi-solid form.

In another aspect, the present invention provides a composition fortopical application to the skin of a mammal for repairing, improving orfully healing a skin disorder, disease or condition, or for causing themammal's skin to experience a reduction in pain, soreness or itchiness,or an increase in soothing, softening or conditioning, or a combinationthereof, comprising:

-   -   (a) one or a plurality of active agents, such as hydrocortisone,        wherein the active agents are present in the composition in a        combined amount that is effective for repairing, improving or        healing the mammal's skin, or causing the mammal's skin to        experience a reduction in pain, soreness or itchiness, or an        increase in soothing, softening or conditioning, or a        combination thereof, after a topical application of the        composition to the mammal's skin; and    -   (b) a base composition, wherein the base composition is present        in the composition in an amount that is effective for permitting        the base composition to function effectively as a carrier        vehicle for the active agents when topically applied to the        mammal's skin, and wherein the base composition includes FANCOL        VB, Natunola Castor 1023, Finsolv TN, bees wax, one or a        plurality of plant or plant seed oils, one or a plurality of        fatty alcohols, one or a plurality of fats, and one or a        plurality of flavorings, each in combined amounts that are        effective for collectively forming together a base composition        in a sold or semi-solid form, and wherein the base composition        does not have a bitter taste or odor, has no distinctive taste        or odor or has a pleasant taste or odor, or both.

In yet aspect, the present invention provides a composition for topicalapplication to the skin of a mammal for repairing, improving or fullyhealing a skin disorder, disease or condition, or for causing themammal's skin to experience a reduction in pain, soreness or itchiness,or an increase in soothing, softening or conditioning, or a combinationthereof, consisting of (or consisting essentially of):

-   -   (a) one or a plurality of active agents, such as hydrocortisone,        wherein the active agents are present in the composition in a        combined amount that is effective for repairing, improving or        healing the mammal's skin, or causing the mammal's skin to        experience a reduction in pain, soreness or itchiness, or an        increase in soothing, softening or conditioning, or a        combination thereof, after a topical application of the        composition to the mammal's skin; and    -   (b) a base composition, wherein the base composition is present        in the composition in an amount that is effective for permitting        the base composition to function effectively as a carrier        vehicle for the active agents when topically applied to the        mammal's skin, and wherein the base composition includes FANCOL        VB, Natunola Castor 1023, Finsolv TN, bees wax, one or a        plurality of plant or plant seed oils, one or a plurality of        fatty alcohols, one or a plurality of fats, and one or a        plurality of flavorings, each in combined amounts that are        effective for collectively forming together a base composition        in a sold or semi-solid form, and wherein the base composition        does not have a bitter taste or odor, has no distinctive taste        or odor or has a pleasant taste or odor, or both.

Original (Specific) Formulations

In another aspect, the present invention provides a composition fortopical application to the skin of a mammal for repairing, improving orfully healing a skin disorder, disease or condition, or for causing themammal's skin to experience a reduction in pain, soreness or itchiness,or an increase in soothing, softening or conditioning, or a combinationthereof, comprising:

-   -   (a) one or a plurality of active agents, such as hydrocortisone,        wherein the active agents are present in the composition in a        combined amount ranging from about 0.1 to about 5 weight        percent; and    -   (b) a base composition, wherein the base composition is present        in the composition in an amount ranging from about 95 to about        99.9 weight percent, and wherein the base composition includes:        -   (1) FANCOL VB, wherein the FANCOL VB is present in the base            composition in an amount ranging from about 9 to about 25            weight percent;        -   (2) Natunola Castor 1023, wherein the Natunola Castor 1023            is present in the base composition in an amount ranging from            about 16 to about 39 weight percent;        -   (3) Finsolv TN, wherein the Finsolv TN is present in the            base composition in an amount ranging from about 9 to about            25 weight percent;        -   (4) bees wax, wherein the bees wax is present in the base            composition in an amount ranging from about 18 to about 43            weight percent;        -   (5) optionally, one or a plurality of plant oils or plant            seed oils, wherein the plant or plant seed oils are present            in the base composition in a combined amount ranging from            about 0 to about 24 weight percent;        -   (6) optionally, one or a plurality of fatty alcohols,            wherein the fatty alcohols are present in the base            composition in a combined amount ranging from about 0 to            about 22 weight percent;        -   (7) optionally, one or a plurality of fats, wherein the fats            are present in the base composition in a combined amount            ranging from about 0 to about 9 weight percent; and        -   (8) optionally, one or a plurality of flavorings, wherein            the flavorings are present in the base composition in a            combined amount ranging from about 0 to about 3.5 weight            percent;            wherein the composition is in a sold or semi-solid form.

In still another aspect, the present invention provides a compositionfor topical application to the skin of a mammal for repairing, improvingor fully healing a skin disorder, disease or condition, or for causingthe mammal's skin to experience a reduction in pain, soreness oritchiness, or an increase in soothing, softening or conditioning, or acombination thereof, consisting of (or consisting essentially of):

-   -   (a) one or a plurality of active agents, such as hydrocortisone,        wherein the active agents are present in the composition in a        combined amount ranging from about 0.1 to about 5 weight        percent; and    -   (b) a base composition, wherein the base composition is present        in the composition in an amount ranging from about 95 to about        99.9 weight percent, and wherein the base composition includes:        -   (1) FANCOL VB, wherein the FANCOL VB is present in the base            composition in an amount ranging from about 9 to about 25            weight percent;        -   (2) Natunola Castor 1023, wherein the Natunola Castor 1023            is present in the base composition in an amount ranging from            about 16 to about 39 weight percent;        -   (3) Finsolv TN, wherein the Finsolv TN is present in the            base composition in an amount ranging from about 9 to about            25 weight percent;        -   (4) bees wax, wherein the bees wax is present in the base            composition in an amount ranging from about 18 to about 43            weight percent;        -   (5) optionally, one or a plurality of plant oils or plant            seed oils, wherein the plant or plant seed oils are present            in the base composition in a combined amount ranging from            about 0 to about 24 weight percent;        -   (6) optionally, one or a plurality of fatty alcohols,            wherein the fatty alcohols are present in the base            composition in a combined amount ranging from about 0 to            about 22 weight percent;        -   (7) optionally, one or a plurality of fats, wherein the fats            are present in the base composition in a combined amount            ranging from about 0 to about 9 weight percent; and        -   (8) optionally, one or a plurality of flavorings, wherein            the flavorings are present in the base composition in a            combined amount ranging from about 0 to about 3.5 weight            percent;            wherein the composition is in a sold or semi-solid form.

In another aspect, the present invention provides a composition fortopical application to the skin of a mammal for repairing, improving orfully healing a skin disorder, disease or condition, or for causing themammal's skin to experience a reduction in pain, soreness or itchiness,or an increase in soothing, softening or conditioning, or a combinationthereof, comprising:

-   -   (a) one or a plurality of active agents, such as hydrocortisone,        wherein the active agents are present in the composition in a        combined amount ranging from about 0.1 to about 5 weight        percent; and    -   (b) a base composition, wherein the base composition is present        in the composition in an amount ranging from about 95 to about        99.9 weight percent, and wherein the base composition includes:        -   (1) FANCOL VB, wherein the FANCOL VB is present in the base            composition in an amount ranging from about 9 to about 13            weight percent;        -   (2) Natunola Castor 1023, wherein the Natunola Castor 1023            is present in the base composition in an amount ranging from            about 16 to about 20 weight percent;        -   (3) Finsolv TN, wherein the Finsolv TN is present in the            base composition in an amount ranging from about 9 to about            13 weight percent;        -   (4) bees wax, wherein the bees wax is present in the base            composition in an amount ranging from about 18 to about 22            weight percent;        -   (5) one or more plant or plant seed oils, wherein the plant            or plant seed oils are present in the base composition in a            combined amount ranging from about 0.1 to about 24 weight            percent;        -   (6) one or more fatty alcohols, wherein the fatty alcohols            are present in the base composition in a combined amount            ranging from about 0.1 to about 22 weight percent;        -   (7) one or more fats, wherein the fats are present in the            base composition in a combined amount ranging from about 0.1            to about 9 weight percent; and        -   (8) optionally, one or a plurality of flavorings, wherein            the flavorings are present in the base composition in an            amount ranging from about 0 to about 3.5 weight percent;            wherein the composition is in a sold or semi-solid form.

In another aspect, the present invention provides a composition fortopical application to the skin of a mammal for repairing, improving orfully healing a skin disorder, disease or condition, or for causing themammal's skin to experience a reduction in pain, soreness or itchiness,or an increase in soothing, softening or conditioning, or a combinationthereof, consisting of (or consisting essentially of):

-   -   (a) one or a plurality of active agents, such as hydrocortisone,        wherein the active agents are present in the composition in a        combined amount ranging from about 0.1 to about 5 weight        percent; and    -   (b) a base composition, wherein the base composition is present        in the composition in an amount ranging from about 95 to about        99.9 weight percent, and wherein the base composition includes:        -   (1) FANCOL VB, wherein the FANCOL VB is present in the base            composition in an amount ranging from about 9 to about 13            weight percent;        -   (2) Natunola Castor 1023, wherein the Natunola Castor 1023            is present in the base composition in an amount ranging from            about 16 to about 20 weight percent;        -   (3) Finsolv TN, wherein the Finsolv TN is present in the            base composition in an amount ranging from about 9 to about            13 weight percent;        -   (4) bees wax, wherein the bees wax is present in the base            composition in an amount ranging from about 18 to about 22            weight percent;        -   (5) one or more plant or plant seed oils, wherein the plant            or plant seed oils are present in the base composition in a            combined amount ranging from about 0.1 to about 24 weight            percent;        -   (6) one or more fatty alcohols, wherein the fatty alcohols            are present in the base composition in a combined amount            ranging from about 0.1 to about 22 weight percent;        -   (7) one or more fats, wherein the fats are present in the            base composition in a combined amount ranging from about 0.1            to about 9 weight percent; and        -   (8) optionally, one or a plurality of flavorings, wherein            the flavorings are present in the base composition in an            amount ranging from about 0 to about 3.5 weight percent;            wherein the composition is in a sold or semi-solid form.

Subsequent (Improved) Formulations

In another aspect, the present invention provides a composition fortopical application to the skin of a mammal for repairing, improving orfully healing a skin disorder, disease or condition, or for causing themammal's skin to experience a reduction in pain, soreness or itchiness,or an increase in soothing, softening or conditioning, or a combinationthereof, comprising:

-   -   (a) one or a plurality of active agents, such as hydrocortisone,        wherein the active agents are present in the composition in a        combined amount ranging from about 0.1 to about 5 weight        percent;    -   (b) FANCOL VB, wherein the FANCOL VB is present in the        composition in an amount ranging from about 6 to about 25 weight        percent;    -   (c) Natunola Castor 1023, wherein the Natunola Castor 1023 is        present in the composition in an amount ranging from about 5 to        about 39 weight percent;    -   (d) Finsolv TN, wherein the Finsolv TN is present in the        composition in an amount ranging from about 9 to about 25 weight        percent;    -   (e) bees wax, wherein the bees wax is present in the composition        in an amount ranging from about 6 to about 43 weight percent;    -   (f) optionally, one or a plurality of plant oils or plant seed        oils, wherein the plant or plant seed oils are present in the        composition in a combined amount ranging from about 0 to about        37.0 (37.5 if no flavoring ingredient is present) weight        percent;    -   (g) optionally, one or a plurality of fatty alcohols, wherein        the fatty alcohols are present in the composition in a combined        amount ranging from about 0 to about 25 weight percent;    -   (h) optionally, one or a plurality of fats, wherein the fats are        present in the composition in a combined amount ranging from        about 0 to about 12 weight percent; and    -   (i) optionally, one or a plurality of flavorings, wherein the        flavorings are present in the base composition in a combined        amount ranging from about 0 to about 3.5 weight percent;        wherein the composition is in a sold or semi-solid form.

Preferred subsequent (improved) active agent-containing compositions ofthe invention include those that are described below.

Non-Flavored Compositions Including Active Agent(s)

(OTC and No Flavor)

In another aspect, the present invention provides a composition fortopical application to the skin of a mammal for repairing, improving orfully healing a skin disorder, disease or condition, or for causing themammal's skin to experience a reduction in pain, soreness or itchiness,or an increase in soothing, softening or conditioning, or a combinationthereof, comprising:

-   -   (a) one or a plurality of active agents, such as hydrocortisone,        wherein the active agents are present in the composition in a        combined amount ranging from about 0.1 to about 3 weight        percent;    -   (b) FANCOL VB, wherein the FANCOL VB is present in the        composition in an amount ranging from about 6 to about 16 weight        percent;    -   (c) Natunola Castor 1023, wherein the Natunola Castor 1023 is        present in the composition in an amount ranging from about 5 to        about 15 weight percent;    -   (d) Finsolv TN, wherein the Finsolv TN is present in the        composition in an amount ranging from about 10 to about 20        weight percent;    -   (e) bees wax, wherein the bees wax is present in the composition        in an amount ranging from about 6 to about 16 weight percent;    -   (f) one or a plurality of plant oils or plant seed oils, wherein        the plant or plant seed oils are present in the composition in a        combined amount ranging from about 12.5 to about 37.5 weight        percent;    -   (g) one or a plurality of fatty alcohols, wherein the fatty        alcohols are present in the composition in a combined amount        ranging from about 15 to about 25 weight percent; and    -   (h) one or a plurality of fats, wherein the fats are present in        the composition in a combined amount ranging from about 2 to        about 12 weight percent;        wherein the composition is in a sold or semi-solid form.

In still another aspect, the present invention provides a compositionfor topical application to the skin of a mammal for repairing, improvingor fully healing a skin disorder, disease or condition, or for causingthe mammal's skin to experience a reduction in pain, soreness oritchiness, or an increase in soothing, softening or conditioning, or acombination thereof, consisting of (or consisting essentially of):

-   -   (a) one or a plurality of active agents, such as hydrocortisone,        wherein the active agents are present in the composition in a        combined amount ranging from about 0.1 to about 3 weight        percent;    -   (b) FANCOL VB, wherein the FANCOL VB is present in the        composition in an amount ranging from about 6 to about 16 weight        percent;    -   (c) Natunola Castor 1023, wherein the Natunola Castor 1023 is        present in the composition in an amount ranging from about 5 to        about 15 weight percent;    -   (d) Finsolv TN, wherein the Finsolv TN is present in the        composition in an amount ranging from about 10 to about 20        weight percent;    -   (e) bees wax, wherein the bees wax is present in the composition        in an amount ranging from about 6 to about 16 weight percent;    -   (f) one or a plurality of plant oils or plant seed oils, wherein        the plant or plant seed oils are present in the composition in a        combined amount ranging from about 12.5 to about 37.5 weight        percent;    -   (g) one or a plurality of fatty alcohols, wherein the fatty        alcohols are present in the composition in a combined amount        ranging from about 15 to about 25 weight percent; and    -   (h) one or a plurality of fats, wherein the fats are present in        the composition in a combined amount ranging from about 2 to        about 12 weight percent;        wherein the composition is in a sold or semi-solid form.

Flavored Compositions Including Active Agent(s)

(OTC and Including Flavoring)

In another aspect, the present invention provides a composition fortopical application to the skin of a mammal for repairing, improving orfully healing a skin disorder, disease or condition, or for causing themammal's skin to experience a reduction in pain, soreness or itchiness,or an increase in soothing, softening or conditioning, or a combinationthereof, comprising:

-   -   (a) one or a plurality of active agents, such as hydrocortisone,        wherein the active agents are present in the composition in a        combined amount ranging from about 0.1 to about 3 weight        percent;    -   (b) FANCOL VB, wherein the FANCOL VB is present in the        composition in an amount ranging from about 6 to about 16 weight        percent;    -   (c) Natunola Castor 1023, wherein the Natunola Castor 1023 is        present in the composition in an amount ranging from about 5 to        about 15 weight percent;    -   (d) Finsolv TN, wherein the Finsolv TN is present in the        composition in an amount ranging from about 10 to about 20        weight percent;    -   (e) bees wax, wherein the bees wax is present in the composition        in an amount ranging from about 6 to about 16 weight percent;    -   (f) one or a plurality of plant oils or plant seed oils, wherein        the plant or plant seed oils are present in the composition in a        combined amount ranging from about 12.0 to about 37.0 weight        percent;    -   (g) one or a plurality of fatty alcohols, wherein the fatty        alcohols are present in the composition in a combined amount        ranging from about 15 to about 25 weight percent;    -   (h) one or a plurality of fats, wherein the fats are present in        the composition in a combined amount ranging from about 2 to        about 12 weight percent; and    -   (i) one or a plurality of flavorings, where the flavorings are        present in the composition in a combined amount ranging from        about 0.1 to about 2.5 weight percent;        wherein the composition is in a sold or semi-solid form.

In another aspect, the present invention provides a composition fortopical application to the skin of a mammal for repairing, improving orfully healing a skin disorder, disease or condition, or for causing themammal's skin to experience a reduction in pain, soreness or itchiness,or an increase in soothing, softening or conditioning, or a combinationthereof, consisting of (or consisting essentially of):

-   -   (a) one or a plurality of active agents, such as hydrocortisone,        wherein the active agents are present in the composition in a        combined amount ranging from about 0.1 to about 3 weight        percent;    -   (b) FANCOL VB, wherein the FANCOL VB is present in the        composition in an amount ranging from about 6 to about 16 weight        percent;    -   (c) Natunola Castor 1023, wherein the Natunola Castor 1023 is        present in the composition in an amount ranging from about 5 to        about 15 weight percent;    -   (d) Finsolv TN, wherein the Finsolv TN is present in the        composition in an amount ranging from about 10 to about 20        weight percent;    -   (e) bees wax, wherein the bees wax is present in the composition        in an amount ranging from about 6 to about 16 weight percent;    -   (f) one or a plurality of plant oils or plant seed oils, wherein        the plant or plant seed oils are present in the composition in a        combined amount ranging from about 12.0 to about 37.0 weight        percent;    -   (g) one or a plurality of fatty alcohols, wherein the fatty        alcohols are present in the composition in a combined amount        ranging from about 15 to about 25 weight percent;    -   (h) one or a plurality of fats, wherein the fats are present in        the composition in a combined amount ranging from about 2 to        about 12 weight percent; and    -   (i) one or a plurality of flavorings, where the flavorings are        present in the composition in a combined amount ranging from        about 0.1 to about 2.5 weight percent;        wherein the composition is in a sold or semi-solid form.

Method of Treatment

In still another aspect, the present invention provides a method forrepairing, improving or fully healing a skin disorder, disease orcondition of a mammal, or for causing the mammal's skin to experience areduction in pain, soreness or itchiness, or an increase in soothing,softening or conditioning, or a combination thereof, comprisingtopically applying to the mammal's skin on a regular basis at least oneor two applications of one of the above compositions, wherein the amountof the composition that is applied to the skin of the mammal is anamount that is effective for repairing, improving or fully healing askin disorder, disease or condition of the mammal, or for causing themammal's skin to experience a reduction in pain, soreness or itchiness,or an increase in soothing, softening or conditioning, or a combinationthereof, and wherein the temperature of the composition is optionallyelevated to a temperature above ambient temperature prior to topicallyapplying the composition to the mammal's skin.

In still another aspect, the present invention provides a method forrepairing, improving or fully healing a skin disorder, disease orcondition of a mammal, or for causing the mammal's skin to experience areduction in pain, soreness or itchiness, or an increase in soothing,softening or conditioning, or a combination thereof, consisting of (orconsisting essentially of) topically applying to the mammal's skin on aregular basis at least one or two applications of one of the abovecompositions, wherein the amount of the composition that is applied tothe skin of the mammal is an amount that is effective for repairing,improving or fully healing a skin disorder, disease or condition of themammal, or for causing the mammal's skin to experience a reduction inpain, soreness or itchiness, or an increase in soothing, softening orconditioning, or a combination thereof.

Methods of Production

Original (Specific) Formulations

In still another aspect, the present invention provides a method forproducing one of the above compositions in a solid or semi-solid formcomprising the following steps in any suitable order:

-   -   (a) optionally, heating a combined amount of one or a plurality        of plant oils that are sufficient, in combination with one or        more other ingredients, for producing a composition in a solid        or semi-solid form to a temperature, and for a period of time,        that are effective for evenly heating the plant oil(s);    -   (b) adding an amount of FANCOL VB that is sufficient, in a        combination with one or more other method ingredients, for        producing a composition in a solid or semi-solid form to any        plant oils heated in step (a), and heating the FANCOL VB at a        temperature, and for a period of time, that are effective for        evenly heating the FANCOL VB, and for dissolving the FANCOL VB        in any such plant oils;    -   (c) adding an amount of Natunola Castor 1023 that is sufficient,        in a combination with one or more other method ingredients, for        producing a composition in a solid or semi-solid form to the        product of step (b), and heating the Natunola Castor 1023 at a        temperature, and for a period of time, that are effective for        dissolving the Natunola Castor 1023 in such product;    -   (d) adding an amount of bees wax that is sufficient, in a        combination with one or more other method ingredients, for        producing a composition in a solid or semi-solid form to the        product of step (c), and heating the bees wax at a temperature,        and for a period of time, that are effective for dissolving the        bees wax in such product;    -   (e) optionally, adding a combined amount of one or a plurality        of fatty alcohols that are sufficient, in a combination with one        or more other method ingredients, for producing a composition in        a solid or semi-solid form to the product of step (d), and        heating the fatty alcohols at a temperature, and for a period of        time, that are effective for dissolving the fatty alcohols in        such product;    -   (f) optionally, adding a combined amount of one or a plurality        of fats that are sufficient for producing, in a combination with        one or more other method ingredients, a composition in a solid        or semi-solid form to the product of step (d) or step (e), and        heating the fats at a temperature, and for a period of time,        that are effective for dissolving the fats in such product;    -   (g) adding an amount of Finsolv TN that is sufficient, in a        combination with one or more other method ingredients, for        producing a composition in a solid or semi-solid form to the        product of step (d), (e) or (f), and heating the Finsolv TN at a        temperature, and for a period of time, that are effective for        dissolving the Finsolv TN in such product;    -   (h) cooling the mixture of step (g) to a temperature that        permits one or a plurality of active ingredients to be mixed        therewith out significantly reducing the activities of the        active ingredients, or rending them inactive;    -   (i) mixing a combined amount of one or a plurality of active        ingredients that is sufficient, when present in a base        composition in solid or semi-solid form, for repairing,        improving or healing a skin disorder, disease or condition of a        mammal, or for causing the mammal's skin to experience a        reduction in pain, soreness or itchiness, or an increase in        soothing, softening or conditioning, or a combination thereof,        with the product of step (h) at a temperature, and for a period        of time, that is sufficient for dissolving the active        ingredients in such product;    -   (j) optionally, cooling the mixture of step (i) to a temperature        that permits one or a plurality of flavorings to be mixed        therewith out significantly reducing the flavor of the        flavorings, or rending them flavorless;    -   (k) optionally, mixing a combined amount of one or a plurality        of flavorings that is sufficient, when present in the        composition, for providing the composition with a desirable or        distinct flavor, or for partially or fully masking one or more        bitter or undesirable flavors present therein, or a combination        thereof, with the product of step (i) or (j) at a temperature,        and for a period of time, that is sufficient for uniformly        distributing the flavorings throughout such product;    -   (l) optionally, determining the concentration of the active        ingredients in the mixture of step (i), (j) or (k); and    -   (m) optionally, pouring or transferring the product of step (i),        (j), (k) or (l) into one or a plurality of molds and allowing        the product to harden, set or solidify therein;        wherein the composition is in a solid or semi-solid form.

Subsequent (Improved) Formulations

Preferred subsequent (improved) methods for producing preferred base andactive agent-containing compositions of the invention include those thatare described below.

Non-Flavored Base Compositions (Non-OTC and No Flavor)

In another aspect, the present invention provides a method for producinga topical base composition that does not include a flavoring ingredientor an active agent in a solid or semi-solid form comprising thefollowing steps in any suitable order:

-   -   (a) heating one or a plurality of plant oils in a combined        amount that is sufficient, in combination with one or more other        ingredients, for producing a composition in a solid or        semi-solid form to a temperature, and for a period of time, that        are effective for evenly heating the plant oil(s), with an        amount of mixing as may be required, for example, from about        75° C. to about 85° C.;    -   (b) adding an amount of FANCOL VB that is sufficient, in a        combination with one or more other method ingredients, for        producing a composition in a solid or semi-solid form to any        plant oils heated in step (a), and heating the FANCOL VB at a        temperature, and for a period of time, that are effective for        evenly heating the FANCOL VB, and for dissolving the FANCOL VB        in any such plant oils, with an amount of mixing as is required,        for example, from about 75° C. to about 85° C.;    -   (c) adding an amount of bees wax that is sufficient, in a        combination with one or more other method ingredients, for        producing a composition in a solid or semi-solid form to the        product of step (b), and heating the bees wax at a temperature,        and for a period of time, that are effective for dissolving the        bees wax in such product, with an amount of mixing as is        required, for example, from about 75° C. to about 85° C.;    -   (d) adding one or a plurality of fatty alcohols in a combined        amount that is sufficient, in a combination with one or more        other method ingredients, for producing a composition in a solid        or semi-solid form to the product of step (c), and heating the        fatty alcohols at a temperature, and for a period of time, that        are effective for dissolving the fatty alcohols in such product,        with an amount of mixing as is required, for example, from about        75° C. to about 85° C.;    -   (e) adding one or a plurality of fats in a combined amount that        is sufficient for producing, in a combination with one or more        other method ingredients, a composition in a solid or semi-solid        form to the product of step (d), and heating the fats at a        temperature, and for a period of time, that are effective for        dissolving the fats in such product, with an amount of mixing as        is required, for example, from about 75° C. to about 85° C.;    -   (f) adding an amount of Finsolv TN that is sufficient, in a        combination with one or more other method ingredients, for        producing a composition in a solid or semi-solid form to the        product of step (e), and heating the Finsolv TN at a        temperature, and for a period of time, that are effective for        dissolving the Finsolv TN in such product, with an amount of        mixing as is required, for example, from about 75° C. to about        85° C.;    -   (g) adding an amount of Natunola Castor 1023 that is sufficient,        in a combination with one or more other method ingredients, for        producing a composition in a solid or semi-solid form to the        product of step (f), and heating the Natunola Castor 1023 at a        temperature, and for a period of time, that are effective for        dissolving the Natunola Castor 1023 in such product, with an        amount of mixing as is required, for example, from about 75° C.        to about 85° C. for a period of time ranging from about 1 hour        to about 1.5 hours; and    -   (h) optionally, pouring or transferring the product of step (g)        into one or a plurality of molds and allowing the product to        partially or fully harden, set or solidify therein;        wherein the composition is in a solid or semi-solid form.

Flavored Base Compositions (Non-OTC, but Including Flavoring)

In another aspect, the present invention provides a method for producinga topical base composition that includes a flavoring ingredient, butthat does not include an active agent, in a solid or semi-solid formcomprising the following steps in any suitable order:

-   -   (a) heating one or a plurality of plant oils in a combined        amount that is sufficient, in combination with one or more other        ingredients, for producing a composition in a solid or        semi-solid form to a temperature, and for a period of time, that        are effective for evenly heating the plant oil(s), with an        amount of mixing as is required, for example, from about 75° C.        to about 85° C.;    -   (b) adding an amount of FANCOL VB that is sufficient, in a        combination with one or more other method ingredients, for        producing a composition in a solid or semi-solid form to any        plant oils heated in step (a), and heating the FANCOL VB at a        temperature, and for a period of time, that are effective for        evenly heating the FANCOL VB, and for dissolving the FANCOL VB        in any such plant oils, with an amount of mixing as is required,        for example, from about 75° C. to about 85° C.;    -   (c) adding an amount of bees wax that is sufficient, in a        combination with one or more other method ingredients, for        producing a composition in a solid or semi-solid form to the        product of step (b), and heating the bees wax at a temperature,        and for a period of time, that are effective for dissolving the        bees wax in such product, with an amount of mixing as is        required, for example, from about 75° C. to about 85° C.;    -   (d) adding one or a plurality of fatty alcohols in a combined        amount that is sufficient, in a combination with one or more        other method ingredients, for producing a composition in a solid        or semi-solid form to the product of step (c), and heating the        fatty alcohols at a temperature, and for a period of time, that        are effective for dissolving the fatty alcohols in such product,        with an amount of mixing as is required, for example, from about        75° C. to about 85° C.;    -   (e) adding one or a plurality of fats in a combined amount that        is sufficient for producing, in a combination with one or more        other method ingredients, a composition in a solid or semi-solid        form to the product of step (d), and heating the fats at a        temperature, and for a period of time, that are effective for        dissolving the fats in such product, with an amount of mixing as        is required, for example, from about 75° C. to about 85° C.;    -   (f) adding an amount of Finsolv TN that is sufficient, in a        combination with one or more other method ingredients, for        producing a composition in a solid or semi-solid form to the        product of step (e), and heating the Finsolv TN at a        temperature, and for a period of time, that are effective for        dissolving the Finsolv TN in such product, with an amount of        mixing as is required, for example, from about 75° C. to about        85° C.;    -   (g) adding an amount of Natunola Castor 1023 that is sufficient,        in a combination with one or more other method ingredients, for        producing a composition in a solid or semi-solid form to the        product of step (f), and heating the Natunola Castor 1023 at a        temperature, and for a period of time, that are effective for        dissolving the Natunola Castor 1023 in such product, with an        amount of mixing as is required, for example, from about 75° C.        to about 85° C. for a period of time ranging from about 1 hour        to about 1.5 hours;    -   (h) cooling the product of step (g) to a temperature that        permits one or a plurality of flavoring ingredients to be mixed        therewith out significantly reducing the flavor of the flavoring        ingredients, or rending them flavorless, for example, from about        70° C. to about 80° C.;    -   (i) adding one or a plurality of flavoring ingredients in a        combined amount that is sufficient, when present in the        composition, for providing the composition with a desirable or        distinct flavor, or for partially or fully masking one or more        bitter or undesirable flavors present therein, or a combination        thereof, with the product of step (h) at a temperature, and for        a period of time, that is sufficient for distributing the        flavorings throughout such product, for example, from about        70° C. to about 80° C. for a period of time ranging from about        15 to about 20 minutes; and    -   (j) optionally, pouring or transferring the product of step (i)        into one or a plurality of molds and allowing the product to        partially or fully harden, set or solidify therein;        wherein the composition is in a solid or semi-solid form.

Non-Flavored Compositions Including Active Agent(s)

(OTC and No Flavor)

In another aspect, the present invention provides a method for producinga topical active-agent containing composition that does not include aflavoring ingredient in a solid or semi-solid form comprising thefollowing steps in any suitable order:

-   -   (a) heating one or a plurality of plant oils in a combined        amount that is sufficient, in combination with one or more other        ingredients, for producing a composition in a solid or        semi-solid form to a temperature, and for a period of time, that        are effective for evenly heating the plant oil(s), for example,        with an amount of mixing as is required, from about 75° C. to        about 85° C.;    -   (b) adding an amount of FANCOL VB that is sufficient, in a        combination with one or more other method ingredients, for        producing a composition in a solid or semi-solid form to any        plant oils heated in step (a), and heating the FANCOL VB at a        temperature, and for a period of time, that are effective for        evenly heating the FANCOL VB, and for dissolving the FANCOL VB        in any such plant oils, with an amount of mixing as is required,        for example, from about 75° C. to about 85° C.;    -   (c) adding an amount of bees wax that is sufficient, in a        combination with one or more other method ingredients, for        producing a composition in a solid or semi-solid form to the        product of step (b), and heating the bees wax at a temperature,        and for a period of time, that are effective for dissolving the        bees wax in such product, with an amount of mixing as is        required, for example, from about 75° C. to about 85° C.;    -   (d) adding one or a plurality of fatty alcohols in a combined        amount that is sufficient, in a combination with one or more        other method ingredients, for producing a composition in a solid        or semi-solid form to the product of step (c), and heating the        fatty alcohols at a temperature, and for a period of time, that        are effective for dissolving the fatty alcohols in such product,        with an amount of mixing as is required, for example, from about        75° C. to about 85° C.;    -   (e) adding one or a plurality of fats in a combined amount that        is sufficient for producing, in a combination with one or more        other method ingredients, a composition in a solid or semi-solid        form to the product of step (d), and heating the fats at a        temperature, and for a period of time, that are effective for        dissolving the fats in such product, with an amount of mixing as        is required, for example, from about 75° C. to about 85° C.;    -   (f) adding an amount of Finsolv TN that is sufficient, in a        combination with one or more other method ingredients, for        producing a composition in a solid or semi-solid form to the        product of step (e), and heating the Finsolv TN at a        temperature, and for a period of time, that are effective for        dissolving the Finsolv TN in such product, with an amount of        mixing as is required, for example, from about 75° C. to about        85° C.;    -   (g) adding an amount of Natunola Castor 1023 that is sufficient,        in a combination with one or more other method ingredients, for        producing a composition in a solid or semi-solid form to the        product of step (f), and heating the Natunola Castor 1023 at a        temperature, and for a period of time, that are effective for        dissolving the Natunola Castor 1023 in such product, with an        amount of mixing as is required, for example, from about 75° C.        to about 85° C. for a period of time ranging from about 1 hour        to about 1.5 hours;    -   (h) adding one or a plurality of active ingredients in a        combined amount that is sufficient, when present in a product of        step (g) in a solid or semi-solid form, for repairing, improving        or fully healing a skin disorder, disease, adverse condition or        other malady of a mammal, or for causing the mammal's skin to        experience a reduction in pain, soreness or itchiness, or an        increase in soothing, softening or conditioning, or a        combination thereof, with the product of step (g) at a        temperature, and for a period of time, that is sufficient for        dissolving the active ingredients in such product, for example,        from about 75° C. to about 85° C.; and    -   (i) optionally, pouring or transferring the product of step (h)        into one or a plurality of molds and allowing the product to        partially or fully harden, set or solidify therein;        wherein the composition is in a solid or semi-solid form.

Flavored Compositions Including Active Agent(s)

(OTC and Including Flavoring)

In another aspect, the present invention provides a method for producinga topical active-agent containing composition that includes at least oneflavoring ingredient in a solid or semi-solid form comprising thefollowing steps in any suitable order:

-   -   (a) heating one or a plurality of plant oils in a combined        amount that is sufficient, in combination with one or more other        ingredients, for producing a composition in a solid or        semi-solid form to a temperature, and for a period of time, that        are effective for evenly heating the plant oil(s), with an        amount of mixing as is required, for example, from about 75° C.        to about 85° C.;    -   (b) adding an amount of FANCOL VB that is sufficient, in a        combination with one or more other method ingredients, for        producing a composition in a solid or semi-solid form to any        plant oils heated in step (a), and heating the FANCOL VB at a        temperature, and for a period of time, that are effective for        evenly heating the FANCOL VB, and for dissolving the FANCOL VB        in any such plant oils, with an amount of mixing as is required,        for example, from about 75° C. to about 85° C.;    -   (c) adding an amount of bees wax that is sufficient, in a        combination with one or more other method ingredients, for        producing a composition in a solid or semi-solid form to the        product of step (b), and heating the bees wax at a temperature,        and for a period of time, that are effective for dissolving the        bees wax in such product, with an amount of mixing as is        required, for example, from about 75° C. to about 85° C.;    -   (d) adding one or a plurality of fatty alcohols in a combined        amount that is sufficient, in a combination with one or more        other method ingredients, for producing a composition in a solid        or semi-solid form to the product of step (c), and heating the        fatty alcohols at a temperature, and for a period of time, that        are effective for dissolving the fatty alcohols in such product,        with an amount of mixing as is required, for example, from about        75° C. to about 85° C.;    -   (e) adding one or a plurality of fats in a combined amount that        is sufficient for producing, in a combination with one or more        other method ingredients, a composition in a solid or semi-solid        form to the product of step (d), and heating the fats at a        temperature, and for a period of time, that are effective for        dissolving the fats in such product, with an amount of mixing as        is required, for example, from about 75° C. to about 85° C.;    -   (f) adding an amount of Finsolv TN that is sufficient, in a        combination with one or more other method ingredients, for        producing a composition in a solid or semi-solid form to the        product of step (e), and heating the Finsolv TN at a        temperature, and for a period of time, that are effective for        dissolving the Finsolv TN in such product, with an amount of        mixing as is required, for example, from about 75° C. to about        85° C.;    -   (g) adding an amount of Natunola Castor 1023 that is sufficient,        in a combination with one or more other method ingredients, for        producing a composition in a solid or semi-solid form to the        product of step (f), and heating the Natunola Castor 1023 at a        temperature, and for a period of time, that are effective for        dissolving the Natunola Castor 1023 in such product, with an        amount of mixing as is required, for example, from about 75° C.        to about 85° C. for a period of time ranging from about 1 hour        to about 1.5 hours;    -   (h) adding one or a plurality of active ingredients in a        combined amount that is sufficient, when present in a product of        step (g) in a solid or semi-solid form, for repairing, improving        or fully healing a skin disorder, disease, adverse condition or        other malady of a mammal, or for causing the mammal's skin to        experience a reduction in pain, soreness or itchiness, or an        increase in soothing, softening or conditioning, or a        combination thereof, with the product of step (g) at a        temperature, and for a period of time, that is sufficient for        dissolving the active ingredients in such product, for example,        from about 75° C. to about 85° C.;    -   (i) cooling the product of step (h) to a temperature that        permits one or a plurality of flavoring ingredients to be mixed        therewith out significantly reducing the flavor of the flavoring        ingredients, or rending them flavorless, for example, from about        70° C. to about 80° C.;    -   (j) adding one or a plurality of flavoring ingredients in a        combined amount that is sufficient, when present in the        composition, for providing the composition with a desirable or        distinct flavor, or for partially or fully masking one or more        bitter or undesirable flavors present therein, or a combination        thereof, with the product of step (i) at a temperature, and for        a period of time, that is sufficient for distributing the        flavorings throughout such product, for example, from about        70° C. to about 80° C. for a period of time ranging from about        15 to about 20 minutes; and    -   (k) optionally, pouring or transferring the product of step (j)        into one or a plurality of molds and allowing the product to        partially or fully harden, set or solidify therein;        wherein the composition is in a solid or semi-solid form.

In yet other aspects, the present invention provides compositions thatare produced by the above methods.

BRIEF DESCRIPTION OF THE DRAWINGS

The patent or application file contains at least one drawing and/orphotograph executed in color. Copies of this patent or patentapplication publication with color drawing(s) and/or photograph(s) willbe provided by the Office upon request and payment of the necessary fee.

FIG. 1 is a photograph showing two roll-up, stick-shaped,hydrocortisone-containing compositions of the invention, prepared in asolid form in a manner described in Example 1, and packaged into twovery different sized plastic containers (having corresponding plasticlids). The smaller sized container includes about 0.15 ounce of thecomposition, and measures about

6.0 cm in length and about 1.5 cm in diameter, and would likely be usedwith lips, and the larger sized container includes about 0.50 ounce ofthe composition, and measures about 7.6 cm in length and about 2.0 cm indiameter, and would likely be used with larger areas of the skin orbody. As is shown in FIG. 1, the lower portion of each of the containers(farthest away from the lids) may be rotated or twisted in a counterclockwise (or clockwise or other) manner to forcibly cause the solidcompositions to protrude outwards from the containers, therebypermitting a user to topically apply the protruding solid compositionsto one or more areas of the user's skin. The quarter shown in FIG. 1 isillustrated for the purposes of having a size comparison of the twodifferent sized containers shown in FIG. 1.

FIG. 2 is a photograph showing the left forearm of a sixteen-year-oldmale patient with eczema, as the forearm was present prior to receivingany type of treatment for the two plaques (elevated, solid, superficiallesions greater than 0.5 cm in diameter) appearing thereon.

FIG. 3 is a photograph showing the same forearm (with two plaques) thatis shown in FIG. 2 (i.e., a view that is closer up).

FIG. 4 is a photograph showing the left wrist of the same male patientdiscussed in FIGS. 2 and 3, as the wrist was present prior to receivingany type of treatment for the eczema appearing thereon.

FIG. 5 is a photograph showing the same forearm that is shown in FIG. 2,but as the forearm existed after being treated only with ahydrocortisone-containing solid composition of the invention, preparedin the manner described in Example 1, and having the larger size shownin FIG. 1, with twenty applications of about 0.5 ml/application of thecomposition being applied to the forearm spaced equally apart over aperiod of seven days. FIG. 5 shows that the two plaques that are presenton the forearm shown in FIG. 2 completely disappeared (i.e., had a 100%improvement). FIG. 5 also shows the same wrist that is shown in FIG. 4,but as the wrist existed after being treated only with ahydrocortisone-containing solid composition of the invention, preparedin the manner described in Example 1, and having the larger size shownin FIG. 1, with thirty applications of the composition being applied tothe wrist spaced equally apart over a period of seven days. FIG. 5 showsthat the eczema that is present on the wrist in FIG. 4 completelydisappeared (i.e., had a 100% improvement).

FIG. 6 is a photograph showing the full face of the same male patientdiscussed in FIGS. 2 and 3, as the face was present prior to receivingany type of treatment for the dry skin appearing thereon.

FIG. 7 is a photograph showing the chin area (with eczema) of the sameface that is shown in FIG. 6 (i.e., a view that is closer up).

FIG. 8 is a photograph showing the same face that is shown in FIG. 6(including the same chin that is shown in FIG. 7), but as the face (andchin) existed after being treated only with a hydrocortisone-containingsolid composition of the invention, prepared in the manner described inExample 1, and having the larger size shown in FIG. 1, with twentyapplications of about 0.5 ml/application being applied to the facespaced equally apart over a period of seven days. FIG. 8 shows that thedry skin (on the lips) that is present on the face and the eczema thatis present on the chin in FIGS. 6 and 7, respectively, completelydisappeared (i.e., had a 100% improvement).

FIG. 9 is a set of two photographs showing the dorsal aspect of the lefthand of a fifty-year-old female patient having psoriasis, whose initialsare PT. FIG. 9A shows this hand as it was present prior to receiving anytype of treatment with any compositions of the invention for thedryness, cracks, and cuts appearing thereon, with an emphasis on thethumb and the index finger. FIG. 9B shows the same dorsal aspect that isshown in FIG. 9A, but as this hand existed after being treated only witha hydrocortisone-containing solid composition of the invention in a formof a large solid stick, prepared in the manner described in Example 6,and having the larger size shown in FIG. 1, with about 100 applicationsof about 0.5 ml/application of the composition being applied to the palmspaced equally apart over a period of thirty days (i.e., about 3-4applications per day). A comparison of the left hand that is shown inFIG. 9A with the left hand that is shown in FIG. 9B shows that thedryness and cracks that are shown in FIG. 9A are significantlymoisturized and reduced, and that the cuts that are shown in FIG. 9Ahave completely disappeared (i.e., have a 100% improvement).

FIG. 10 is a set of two photographs showing the palmar aspect of thesame left hand of the same female patient that is pictured in FIG. 9.FIG. 10A shows this hand as it was present prior to receiving any typeof treatment with any compositions of the invention for the dryness,cracks, and cuts appearing thereon, with an emphasis on the thumb andthe palm. FIG. 10B shows the same palm that is shown in FIG. 10A, but asthe palm existed after being treated only with ahydrocortisone-containing solid composition of the invention in a formof a large solid stick, prepared in the manner described in Example 6,and having the larger size shown in FIG. 1, with about 100 applicationsof about 0.5 ml/application of the composition being applied to the palmspaced equally apart over a period of thirty days (i.e., about 3-4applications per day). A comparison of the left hand that is shown inFIG. 10A with the left hand that is shown in FIG. 10B shows that thedryness and cracks that are shown in FIG. 10A are significantlymoisturized and reduced, and that the cuts that are shown in FIG. 10Ahave completely disappeared (i.e., have a 100% improvement).

FIG. 11 is a set of two photographs showing the dorsal aspect of theright hand of the same female patient whose left hand is pictured inFIG. 9 and FIG. 10. FIG. 11A shows this hand as it was present prior toreceiving any type of treatment with any compositions of the inventionfor the dryness, cracks, and cuts appearing thereon, with an emphasis onthe thumb, index finger, and knuckles. FIG. 11B shows the same dorsalaspect that is shown in FIG. 11A, but as the hand existed after beingtreated only with a hydrocortisone-containing solid composition of theinvention in a form of a large solid stick, prepared in the mannerdescribed in Example 6, and having the larger size shown in FIG. 1, withabout 100 applications of about 0.5 ml/application of the compositionbeing applied to the palm spaced equally apart over a period of thirtydays (i.e., about 3-4 applications per day). A comparison of the righthand that is shown in FIG. 11A with the right hand that is shown in FIG.11B shows that the dryness and cracks that are shown in FIG. 11A aresignificantly moisturized and reduced, and that the cuts that are shownin FIG. 11A have completely disappeared (i.e., have a 100% improvement).

FIG. 12 is a set of two photographs showing the palmar aspect of theright hand of the same female patient whose left hand is pictured inFIG. 9-11. FIG. 12A shows this hand as it was present prior to receivingany type of treatment with any compositions of the invention for thedryness, cracks, and cuts appearing thereon, with an emphasis on thepalm, thumb, and index finger. FIG. 12B shows the same palm that isshown in FIG. 12A, but as the palm existed after being treated only witha hydrocortisone-containing solid composition of the invention in a formof a large solid stick, prepared in the manner described in Example 6,and having the larger size shown in FIG. 1, with about 100 applicationsof about 0.5 ml/application of the composition being applied to the palmspaced equally apart over a period of thirty days (i.e., about 3-4applications per day). A comparison of the right hand that is shown inFIG. 12A with the right hand that is shown in FIG. 12B shows that thedryness and cracks that are shown in FIG. 12A are significantlymoisturized and reduced, and that the cuts that are shown in FIG. 12Ahave completely disappeared (i.e., have a 100% improvement).

FIG. 13 is a set of two photographs showing the dorsal aspects of theleft and right hands of the same female patient whose hands are picturedin FIGS. 9-12. FIG. 13A shows the left and right hands as they werepresent prior to receiving any type of treatment with any compositionsof the invention for the dryness, cracks, and cuts appearing thereon,with an emphasis on the thumbs, index fingers, and knuckles of bothhands. FIG. 13B shows the same left and right hands that are shown inFIG. 13A, but as the left and right hands existed after being treatedonly with a hydrocortisone-containing solid composition of the inventionin a form of a large solid stick, prepared in the manner described inExample 6, and having the larger size shown in FIG. 1, with about 100applications of about 0.5 ml/application of the composition beingapplied to the palm spaced equally apart over a period of thirty days(i.e., about 3-4 applications per day). A comparison of the left andright hands that are shown in FIG. 13A with the left and right handsthat are shown in FIG. 13B show that the dryness and cracks that areshown in FIG. 13A are significantly moisturized and reduced, and thatthe cuts that are shown in FIG. 13A have completely disappeared (i.e.,have a 100% improvement).

FIG. 14 is a set of two photographs showing the palmar aspects of theleft and right hands of the same female patient whose hands are picturedin FIGS. 9-13. FIG. 14A shows the left and right hands as they werepresent prior to receiving any type of treatment with any compositionsof the invention for the dryness, cracks, and cuts appearing thereon,with an emphasis on the palms, thumbs, and index fingers of both hands.FIG. 14B shows the same left and right hands that are shown in FIG. 14A,but as the left and right hands existed after being treated only with ahydrocortisone-containing solid composition of the invention in a formof a large solid stick, prepared in the manner described in Example 6,and having the larger size shown in FIG. 1, with about 100 applicationsof about 0.5 ml/application of the composition being applied to the palmspaced equally apart over a period of thirty days (i.e., about 3-4applications per day). A comparison of the left and right hands that areshown in FIG. 14A with the left and right hands that are shown in FIG.14B show that the dryness and cracks that are shown in FIG. 14A aresignificantly moisturized and reduced, and that the cuts that are shownin FIG. 14A have completely disappeared (i.e., have a 100% improvement).

FIG. 15 is a set of two photographs showing the face of athirty-five-year-old female patient having seborrheic dermatitis, whoseinitials are SN. FIG. 15A shows this face as it was present prior toreceiving any type of treatment for the erythema of the nasolabial foldsappearing thereon. FIG. 15B shows the same face that is shown in FIG.15A, but as the face existed after being treated only with ahydrocortisone-containing solid composition of the invention in a formof a small solid stick, prepared in the manner described in Example 6,and having the smaller size shown in FIG. 1, with 21 applications ofabout 0.1 ml/application of the composition being applied to thenasolabial folds spaced equally apart over a period of seven days (i.e.,3 applications per day). A comparison of the face that is shown in FIG.15A with the face that is shown in FIG. 15B shows that the scaling anderythema that is shown in FIG. 15A was significantly reduced.

FIG. 16 is a set of two photographs showing the face of aforty-one-year-old male patient having seborrheic dermatitis, whoseinitials are JT. FIG. 16A shows this face as it was present prior toreceiving any type of treatment for the seborrheic dermatitis appearingthereon. FIG. 16B shows the same face that is shown in FIG. 16A, but asthe face existed after being treated only with ahydrocortisone-containing solid composition of the invention in a formof a small solid stick, prepared in the manner described in Example 6,and having the smaller size shown in FIG. 1, with 21 applications ofabout 0.1 ml/application of the composition being applied to theseborrheic dermatitis present on the face spaced equally apart over aperiod of 7 days (i.e., 3 applications per day). A comparison of theface that is shown in FIG. 16A with the face that is shown in FIG. 16Bshows that the seborrheic dermatitis, scaling and erythema that is shownin FIG. 16A was significantly reduced.

FIG. 17 is a set of two photographs showing the face of aseventeen-year-old female patient having eczema, whose initials are SR.FIG. 17A shows this face as it was present prior to receiving any typeof treatment for the eczema appearing thereon. FIG. 17B shows the sameface that is shown in FIG. 17A, but as the face existed after beingtreated only with a hydrocortisone-containing solid composition of theinvention in a form of a small solid stick, prepared in the mannerdescribed in Example 6, and having the smaller size shown in FIG. 1,with 21 applications of about 0.1 ml/application of the compositionbeing applied to the eczema spaced equally apart over a period of 7 days(i.e., 3 applications per day). A comparison of the face that is shownin FIG. 17A with the face that is shown in FIG. 17B shows that theeczema that is shown in FIG. 17A was significantly reduced (by about80%).

FIG. 18 is a set of two photographs showing the left hand of afifty-three-year-old female patient having eczema, whose initials arePR. FIG. 18A shows this patient's left hand as it was present prior toreceiving any type of treatment for the eczema appearing just below thebase of the ring finger. FIG. 18B shows the same hand that is shown inFIG. 18A, but as the hand existed after being treated only with thehydrocortisone-containing solid composition (in the manner describedabove). A comparison of the hand that is shown in FIG. 18A with the handthat is shown in FIG. 18B shows that the eczema that is shown in FIG.18A had completely cleared (i.e., a 100% improvement).

FIG. 19 is a set of two photographs showing the right hand of the samefifty-three-year-old female patient having eczema, whose initials arePR. FIG. 19A shows this patient's right hand as it was present prior toreceiving any type of treatment for the eczema appearing thereon at thebase of the fourth finger. FIG. 19B shows the same hand that is shown inFIG. 19A, but as the hand existed after being treated only with thehydrocortisone-containing solid composition (in the manner describedabove). A comparison of the hand that is shown in FIG. 19A with the handthat is shown in FIG. 19B shows that the eczema that is shown in FIG.19A had completely cleared (i.e., a 100% improvement).

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention may be understood more readily by reference to thefollowing detailed description of the preferred embodiments of theinvention, and to the examples included therein.

Definitions

For purposes of clarity, various terms and phrases used throughout thisspecification and the appended claims are defined in the manner setforth below. If a term or phrase used in this specification, or in theappended claims, is not defined below, or otherwise in thisspecification, the term or phrase should be given its ordinary meaning.

The terms “about” and “approximate” as are used herein meanapproximately, as is known, and may be determined, by those havingordinary skill in the art, and typically includes a variation of anumeric value described herein by ±0.2.

The phrase “ambient temperature” as is used herein means the temperatureof the surroundings, such as the temperature of a particular room.

The phrase “antioxidant agent” as is used herein means an agent that hasan ability to prevent, reduce or aid in the prevention or reduction of,an oxidation, degradation and/or other decomposition of one or moreingredients or components, such as a fat or an oil, and/or to prevent,or aid in the prevention of, oxygen-based damage to hair, skin or othercells. Antioxidant agents include, for example, various tocopherolmixtures, edible acids (citric acid, ascorbic acid and the like),vitamin A, vitamin C, vitamin E, beta-carotene, selenium, magnesium,herbal extracts, such as a Rosemary, Sage, Oregano, Ginger, Marjoram orRosemary Oleoresins extract, plant phenols, such as Vanillin, ellagicacid and Resveratrol, and synthetic antioxidants, such as tertiarybutylhydroquinone (TBHQ), butylated hydroxyamisole (BHA) or butylatedhydroxytoluene (BHT), or mixtures thereof.

The term “balm” as is used herein means a substance that typically isoily in nature, a solid or semi-solid, and soothing to the skin of ahuman being and/or animal when topically applied thereto (eitherimmediately or at a subsequent time after one or a series of multipleapplications), particularly when it includes one or more active agents,such as hydrocortisone, and which may or may not have a pleasant (orother smell). Examples of balms include aloe, ChapStick® andcompositions within the present invention.

The phrase “carrier vehicle” as is used herein means a medium for, orcapable of, providing a controlled delivery of one or a plurality ofactive agents to a mammal, or part thereof, such as the skin.

The term “component” as is used herein means a part, portion, element,constituent or ingredient, and is used interchangeably with “ingredient”and “agent.” For example, in connection with a composition of theinvention, this term may mean an ingredient, or combination ofingredients, used in the composition, or a part, portion, element orconstituent thereof, depending upon the context in which this term isused, which may readily be determined by those having ordinary skill inthe art.

The phrase “base” as is used herein refers to a carrier vehicle for oneor a plurality of active agents, such as hydrocortisone, that may beapplied to the skin of a normal and healthy mammal (other than possiblyhaving one more adverse skin conditions, disorders or diseases, as arediscussed herein) in a reasonable quantity over a reasonable period oftime, preferably without an unreasonable risk of harm, injury,inflammation, irritation or allergic response to, or by, the skin, orillness or harm to the mammal. Persons of ordinary skill in the art mayreadily determine whether or not a particular base includes thesecharacteristics.

The phrase “diluent” as is used herein means a substance or agent thatdilutes, facilitates a physical separation of one or more ingredientsand/or makes thinner or weaker. Diluent materials that are suitable foruse with mammals could generally include complex polysaccharides,carbohydrates, smaller sugars (dextrose, sucrose and the like),dicalcium phosphate, tricalcium phosphate, maltodextrin and water.

The term “distinctive” as is used herein means characteristic of,identifying or serving to distinguish. For example, a distinctive tastemay be a bitter taste, a sour taste, a sweet taste, a salty taste, afruity taste, a vanilla taste and/or the like.

The term “eczema” as is used herein means a particular type ofinflammatory reaction of the skin in which there are typically tinyblister-like raised areas (vesicles) in the first stage followed byreddening (erythema), swelling (edema), bumps (papules), and crusting ofthe skin, and finally thickening and scaling of the skin.

The term “effective” as is used herein in connection with a compositioningredient or composition, in many instances, and depending upon thecontext, as may be determined by those having ordinary skill in the art,means that the ingredient, alone or in combination with one or moreother ingredients, provides a composition with one or more of thequalities, characteristics and/or benefits that are described herein, orthat the composition has one or more of such qualities, characteristicsand/or benefits, such as an activity resulting from an active ingredientpresent therein.

The term “emollient” as is used herein means an ingredient, orcombination of ingredients, that increases the softness of the skin,restores the skin and/or helps maintain water and/or oils in the skin.

The term “emulsifier” as is used herein means any substance or agentthat aids in the formation of an emulsion, such as egg yolk, egglecithin, soy lecithin and mono- and di-glycerides.

The term “emulsion” as is used herein means a generally stable andhomogeneous mixture of two liquids that do not normally mix (i.e., theyare immiscible between themselves), such as vegetable oil and water, forexample, milk and mayonnaise. Emulsions can be true colloids or lessstable mixtures, which tend to separate in a short time. An emulsion canoften be broken down (i.e. the liquids separated) by factors such asmechanical manipulation, chemical effects and/or time.

The term “FANCOL VB” as is used herein means Butyrospermum Parkii ButterLimnanthes Alba Seed Oil, which contains, or consists of, vegetablederived lipids and sterol-enriched shea butter extract. Its INCI name isLimnanthes Alba (Meadowfoam) Seed Oil, Butyrospermum Parkii (SheaButter) Extract. It is commercially available from sources that areknown by those having ordinary skill in the art, for example, from TheFanning Corporation (Chicago, Ill.) and Elementis Specialties, Inc.(Hightstown, N.J.).

The term “fat” as is used herein means any of the various saturatedand/or unsaturated (including monounsaturated and polyunsaturated),hydrogenated or unhydrogenated soft solid, semisolid and/or solidorganic compounds that generally comprise the glyceride esters of fattyacids and associated phosphatides, sterols, alcohols, hydrocarbons,ketones and/or related compounds, components thereof and/or mixtures orother combinations thereof. Such components include, but are not limitedto, fatty acids, glycerides (mono-, di- and tri-), ethyl and otheresters of fatty acids, as well as components thereof, and combinationsthereof. Fats occur widely in organic tissue, particularly in thesubcutaneous connective tissue of animals (beef, poultry, pork, lamb,liver and the like), and in the seeds, nuts and fruits of plants. Thereis generally no chemical difference between fats and oils, with the onlydistinction being that fats are generally solid at room temperature andoils are generally liquid at room temperature.

The phrase “fatty acids” as is used herein means carboxylic acids thatgenerally are derived from, or contained in, an animal, vegetable orother fat or oil, whether saturated, unsaturated, monounsaturated,polyunsaturated, aromatic, essential, nonessential, in a cis- ortrans-form, in the ethyl esters, mono-, di- or tri-glycerides, freefatty acids or other forms, and components and combinations of theforegoing. Fatty acids include, but are not limited to, the specificfatty acids identified below:

Number of Number of Common Name Carbon Atoms Double Bonds Butyric Acid 40 Caproic Acid 6 0 Caprylic Acid 8 0 Capric Acid 10 0 Lauric Acid 12 0Myristic Acid 14 0 Palmitic Acid 16 0 Palmitoleic Acid 16 1 Stearic Acid18 0 Oleic Acid 18 1 Linoleic Acid 18 2 Alpha-Linolenic Acid 18 3 (ALA)Gamma-Linolenic Acid 18 3 (GLA) Arachidic Acid 20 0 Gadoleic Acid 20 1Arachidonic Acid (AA) 20 4 Eicosapentaenoic Acid 20 5 (EPA) Behenic Acid22 0 Erucic Acid 22 1 Docosahexaenoic Acid 22 6 Lignoceric Acid 24 0Other fatty acids are known by those of skill in the art. A wide varietyof fatty acids are commercially available from sources known by those ofskill in the art. Also, oils can be separated into their component fattyacids on a capillary column in a gas chromatograph, and the relativefatty acid contents measured. Additional information concerning fattyacids is readily available from the Fatty Acid Producer's Council (NewYork, N.Y.).

The phrase “fatty alcohol” as is used herein means an alcohol that isderived from a fat or oil, which may originate in a plant or plant part,but may also be synthesized in an animal or in algae or the like. Fattyalcohols are often closely related to fatty acids, including omega-3fatty acids. They often have an even number of carbon atoms, andproduction from fatty acids generally yields normal-chain alcohols, inwhich the alcohol group (—OH) attaches to the terminal carbon atom.Other processing can yield iso-alcohols, in which the alcohol attachesto a carbon atom located in the interior of the carbon chain. Fattyalcohols include normal chain alcohols, saturated alcohols, unsaturatedalcohols, acetylenic alcohols, sulfated alcohols, branched chainalcohols and/or the like. Examples of some specific fatty alcoholsinclude, but are not limited to, stearyl alcohol (1-octadecanol),isostearyl alcohol (16-methylheptadecan-1-ol), oleyl alcohol, linoleylalcohol, behenyl alcohol, lignoceryl alcohol, ceryl alcohol, caprylalcohol (1-octanol), capric alcohol (1-decanol, decyl alcohol), laurylalcohol (dodecanol, 1-dodecanol), myristyl alcohol (1-tetradecanol),cetyl alcohol (1-hexadecanol), palmitoleyl alcohol(cis-9-hexadecen-1-ol) and heptadecyl alcohol. Other fatty alcohols areknown by those having ordinary skill in the art.

The term “firm” as is used herein means having a solid and/or compactstructure that is partially or fully resistant to stress or externallyapplied pressure.

The phrase “function effectively” as is used herein means that a basecomposition or active agent-containing composition of the invention hasan ability to provide, produce or have one or more of the benefits andadvantages that are described herein for such compositions, such ashaving an activity provided by an active ingredient present therein.

The term “humans” as is used herein, unless otherwise stated, includeshuman beings that are babies, infants, children or adults.

The term “ingredient” as is used herein interchangeably with “component”and “agent” in connection with compositions described herein.

The abbreviation “INCI” as is used herein means InternationalNomenclature Cosmetic Ingredient.

The term “lipid” as is used herein means any of a group of organiccompounds, including fats, oils, waxes, sterols, and triglycerides, thatgenerally are insoluble in water but soluble in nonpolar organicsolvents, are oily to the touch, and together with carbohydrates andproteins constitute the principal structural material of living cells.

The phrase “liquid” as is used herein means a state of matter, neithersolid nor gas, in which a substance exhibits a characteristic readinessto flow, and the shape of which is generally determined by the containerthat it fills.

The term “mammals” as is used herein includes humans and non-humanmammals, such as animals (dogs, cats, horses, cows, bulls, pigs, goats,sheep, birds, fowl, or the like)).

The phrase “marine oil” as is used herein includes, but is not limitedto, “fish oil” and one or more individual components of marine oil, suchas an omega-3 fatty acid, or a combination thereof. Marine oils include,for example, herring oil, cod oil, anchovy oil, tuna oil, sardine oil,menhaden oil and algae oil.

The phrase “mucosal membrane” as is used herein means a membrane thatlines a body passage that communicate with the air, such as therespiratory and alimentary tracts, and which may have cells and/orassociated glands that secrete mucus.

The phrase “Natunola Castor 1023” as is used herein means a substancethat consists of, or contains, castor oil, glycerine soybean germextract, corn starch and silica. Its INCI name is Ricinus Communis(Castor) Seed Oil (and) Glycine Soja (Soybean) Germ Extract (and) ZeaMays (Corn) Starch (and) Silica,). It is commercially available fromsources that are known by those having ordinary skill in the art, forexample, from Natunola Health Biosciences, Inc. (Winchester, Ontario,Canada) or Natunola Health, Inc. (Winchester, Ontario, Canada).

The term “non-OTC” as is used herein in connection with a topical skincomposition means that the composition typically would not be regulatedin the U.S. by the U.S. Federal Drug Administration (FDA), or by itsstatutes, regulations and rules. Compositions of the invention that donot include any active ingredients, such as hydrocortisone, wouldgenerally be classified as “non-OTC” compositions.

The term “oil” as is used herein means a fat that generally is viscous,liquid or liquefiable at room temperature, and includes mixtures andother combinations of one or more oils and/or components of oils, suchas fatty acids, glycerides and/or ethyl esters of fatty acids (orcomponents thereof).

The phrase “on a regular basis” as is used herein means that acomposition employed in the methods of the invention is applied to theskin of a mammal on a reasonably continuous basis (i.e. without delayingone or more applications for an unreasonably lengthy period of time),for example, a regular application of the composition to the mammal'sskin one, two, three, four, five, six, seven, eight, nine, ten and soforth times within a period of one, two, three, four, five, six, seven,eight, nine, ten and so forth days for a duration of one, two, three,four, five, six, seven, eight, nine, ten and so forth days or weeks.

The abbreviation “OTC” as is used herein in connection with a topicalskin composition means that the composition typically would be regulatedin the U.S. by the U.S. Federal Drug

Administration (FDA), and its statutes, regulations and/or rules, suchas the Federal Food, Drug and Cosmetics Act, which is herebyincorporated herein in its entirety by reference along with itsassociated regulations and rules. For example, compositions of theinvention that include an active ingredient, such as hydrocortisone,would generally be classified as “OTC” compositions. The phrase “plantseed oil” as is used herein means an oil that is extracted, or otherwiseobtained from, either directly or indirectly, a seed of a plant,particularly oily seeds, including one or more individual componentsthereof and mixtures thereof. Plant seed oils include, but are notlimited to, Black Currant seed oil, Borage seed oil, safflower seed oil,sunflower seed oil, sesame seed oil, avocado seed oil, pumpkin seed oil,olive seed oil, coconut seed oil, rapeseed oil, flaxseed (linseed) oil,cottonseed oil, tung oil, meadowfoam seed oil, parsley seed oil, carrotseed oil, fennel fruit oil, parsnip seed oil, coriander seed oil,chervil seed oil, caraway plant oil, celery seed oil and others that aredescribed herein. Other plant seed oils are known by those havingordinary skill in the art.

The phrase “plant oil” as is used herein means an oil that is extracted,or otherwise obtained from, either directly or indirectly, a plant,particularly an oily plant, including one or more individual componentsthereof, and mixtures thereof. Plant oils include, but are not limitedto, Evening Primrose oil, Borage oil, safflower oil, sunflower oil,peanut oil, walnut oil, almond oil, avocado oil, olive oil, corn oil,soy oil, soybean oil, coconut oil, palm oil, palm kernel oil, castoroil, mineral oil and others that are described herein. Other plant oilsare known by those having ordinary skill in the art.

The term “pliable” as is used herein means supple enough to partially(greater than about 0% but less than about 100%) or fully (about 100%)bend without breaking.

The term “plurality” as is used herein means more than one, such as two,three, four, five, six, seven, eight, nine, ten, eleven, twelve,thirteen, fourteen, fifteen, twenty, twenty-five, thirty, thirty-fiveand so forth.

The term “prescription” as is used herein means a written, telephonic orother order, typically made by a medical doctor (physician), for apreparation, distribution and/or administration of a medicine or othertreatment to a patient, or other individual, for example, by apharmacist or pharmacy.

The abbreviation “q.s.” as is used herein means a sufficient quantity,for example, to cause the weight percent of a composition to be 100%, orto obtain a desired effect or benefit. The plant or plant seed oilingredient of the base and active-agent compositions of the invention,when present, such as castor oil, may be varied in a manner desired orrequired to cause the weight percent of the composition to be 100%.

The phrase “room temperature” as is used herein means the temperature ina room, which generally ranges from about 15° C. to about 30° C. (fromabout 59° F. to about 86° F.), and more usually ranges from about 21° C.to about 23° C. (from about 70° F. to about 74° F.). The “ambienttemperature” of a room is “room temperature.”

The phrase “safe for use” as is used herein in connection withcompositions described herein, and methods of the invention, means thatthe compositions, and the components contained therein, and the methods,using reasonable quantities of active and other components, andadministered for reasonable periods of time (such as those quantitiesand periods of time described herein, or as otherwise recommended for aparticular mammal by a physician, veterinarian or other skilledclinician), which may vary for different types of mammals, do not cause,or present an unreasonable risk of harm, damage, defect, disorder,deformity or injury to, or by, an average mammal, or the skin of anaverage mammal, whether or not the mammal has one or more skindisorders, diseases, conditions or maladies.

The phrase “semi-solid” as is used herein means a state of matter thatis intermediate in properties, especially in rigidity, firmness andcompactness, between a solid and a liquid, such as a gel, a cream, anointment and/or the like. A semi-solid composition is typically notrigid, compact or firm. Unlike a solid composition, a user may insert afinger into a pot containing a semi-solid composition, such as petroleumjelly, and scoop a portion of it out with the finger.

The term “shape” as is used herein in connection with base compositionsand active agent-containing compositions includes, but is not limitedto, any of a wide variety of known or unknown shapes of any desired orrequired size, such as circular or oval spheres, square or rectangularcubes or prisms, triangular prisms, square-based pyramids,triangle-based pyramids, cuboid hexagonal prisms, cones, cylindersand/or the like. The shaped of a “stick” as is referred to herein meansa cylinder. The sizes of such shapes (length, width, depth and/or thelike) may be any size that is desired, convenient for use or requiredincluding, but not limited to, from one or a plurality of mm (orsmaller) to one or a plurality of inches or feet. Two cylinder-shapedactive-agent containing compositions, having two very different sizes,are shown in FIG. 1.

The term “skin” as is used herein in connection with human beings meansthe outer integument or covering of the body, containing multiplelayers, including the epidermis (outer most layer, which typicallyranges from about 0.5 to about 1.5 mm in thickness), which itselfincludes the five layers (from bottom to top) of the stratum basale,stratum spinosum, stratum granulosurn, stratum licidum and stratumcorneum, the dermis (or cornium) (mid layer, which typically ranges fromabout 0.3 to about 3.0 mm in thickness), which includes collagen tissue,elastic tissue and reticular fibers, and an upper papillar layer and alower reticular layer, and subcutaneous tissue (below the dermis). As itis used herein, skin includes, but is not limited to, the outer coveringof the face (including the lips, eye lids and outer portions of theears), scalp, neck, arms, legs, hands, feet, fingers, toes, chest,breasts, back, abdomen, genitals and/or the like, and portions or partsthereof, of a human being or non-human mammal, such as an animal. Inconnection with non-human mammals, the term “skin” includes the outercovering of the body that is not fur, hair, feathers and/or the like. Asit is used herein, the term “skin” also includes inner areas orcoverings of the body including, but not limited to, the inside of thenostrils of the nose, the inside of the mouth, the inner ears, insidefolds and areas of female and male genitals, and all mucosal membranes.

The phrase “solid” as is used herein means a state of matter, neitherliquid nor gas, generally having a definite shape and volume, andtypically being rigid, firm and/or compact in substance, but possiblyhaving an ability to be pliable, and to be softened into a less firmand/or rigid state, or melt, upon heating it to a temperature that isabove the melting point of the solid (or to some other temperature thatcauses it to soften, which may be determined by those having ordinaryskill in the art). A “solid” composition is different from a“semi-solid” composition, such as petroleum jelly, as a result of itsrigidness, firmness and/or compactness. For example, a user wouldtypically have an ability to insert a finger into a “semi-solid”composition present in a pot and scoop a portion of the composition outof the pot with the finger. The same user typically would not have anability to do the same with a “solid” composition present in the samepot as a result of the rigidity, firmness and/or compactness of the“solid” composition. However, a “solid” composition, as is describedherein, may be transformed into a “semi-solid” or “liquid” state byapplying heat to the “solid,” causing the “solid” to partially or fullymelt, as is discussed herein (i.e., after the “solid” product has beenproduced).

The phrases “surfactant” and “wetting agents” as are used herein meansubstances or agents that lower the surface tension (tendency of aliquid to reduce its exposed surface to the smallest possible area) of aliquid, generally allowing easier spreading, and/or the interfacialtension between two liquids. Surfactants are usually organic compoundsthat are amphipathic in that they contain both hydrophobic groups (their“tails”) and hydrophilic groups (their “heads”). Therefore, they aretypically sparingly soluble in both organic solvents and water.Surfactants generally reduce the surface tension of water by adsorbingat the air-water interface, and reduce the interfacial tension betweenoil and water by adsorbing at the liquid-liquid interface. Manysurfactants can also assemble in the bulk solution into aggregates thatare known as micelles.

The phrases “topical administration,” “topically administering” and“topically applying” as are used herein mean an application onto theskin (generally onto one or more exposed or outer surfaces thereof, suchas the outermost layer of the epidermis, which is exposed and visuallyobservable), for example, using hands, fingers or a wide variety ofapplicators (roll-up, roll-on or other stick container, tube container,cotton ball, powder puff, Q-tip, pump, brush, mat, cloth and/or thelike). The application may be made, for example, by laying, placing,rubbing, sweeping, pouring, spreading and/or massaging into, or onto,the skin, or by any other convenient or suitable method. Compositionsthat may be applied by topical administration include, but are notlimited to, sticks, lipsticks, waxes, creams, lotions, ointments, balms,gels, glosses, sunscreen preparations, cosmetics, masks, leave-on washesor cleansers, depilatory preparations and/or the like.

The term “viscosity” as is used herein means resistance to flow (of afluid or semi-fluid). Viscosity can be measured using, for example, acommercially available viscometer.

The term “wax” as is used herein means a fatty substance that is oftensolid at room temperature and softens and melts when warmed. Generally,waxes are similar in composition to fats and oils, with the exceptionthat they do not contain glycerides. Some waxes are hydrocarbons, andothers are esters of fatty acids and alcohols. Examples of waxesinclude, but are not limited to, bees wax, lanolin, carnauba,candelilla, ozokerite, bayberry, sugar cane, paraffin, microcrystallineand sorbitol.

The phrase “weight percent” as is used herein refers to the percentweight, for example, of an ingredient that forms a part of a mixture,base composition, active-agent containing composition, other compositionor the like, with the total weight of the mixture, base composition,active-agent containing composition or other composition or the likebeing 100 weight percent, and is a measure of the relative proportionsof two or more quantities in a mixture Thus, weight percent may includeany whole, partial, decimal or fractional number above 0, such as 1, 2,3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22,23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40,41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58,59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76,77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94,95, 96, 97, 98, 99 or 100 (or any amount in between the foregoing, suchas 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9 and so forth).

The phrase “without significantly reducing the activities of the activeingredients” as is used herein means that the active agent(s) do nothave a reduction in activity that is greater than about 50 percent, andpreferably that is not greater than about 40%, and more preferably thatis not greater than about 30%, and still more preferably that is notgreater than about 20%, and even more preferably that is not greaterthan about 10%, and still more preferably that is not greater than about5% (out of 100%). Thus, they have an activity ranging from about 50% toabout 100%, which is preferably about 60% or higher, more preferablyabout 70% or higher, still more preferably about 80% or higher, evenmore preferably about 90% or higher, and still more preferably about 95%or higher, and most preferably 100%.

The phrase “without significantly reducing the flavor of the flavorings”as is used herein means that the flavorings do not have a reduction inflavor that is greater than about 50 percent, and preferably that is notgreater than about 40%, and more preferably that is not greater thanabout 30%, and still more preferably that is not greater than about 20%,and even more preferably that is not greater than about 10%, and stillmore preferably that is not greater than about 5% (out of 100%). Thus,they have a flavor capacity ranging from about 50% to about 100%, whichis preferably about 60% or higher, more preferably about 70% or higher,still more preferably about 80% or higher, even more preferably about90% or higher, and still more preferably about 95% or higher, and mostpreferably 100%.

General Description and Advantages

The present invention provides novel base compositions and relatedtopical active agent-containing compositions including hydrocortisoneand/or one or a plurality of other active agents, which may be employed,for example, in an over-the-counter, prescription or otherpharmaceutical product for human beings or animals having one or aplurality of skin disorders, diseases or adverse conditions, orotherwise, and related methods of production and use. These compositionsmay be present in any suitable, convenient and/or desired form,including liquids, semi-solids and solids in, for example, a cream, anointment, a balm, a paste, a gel, a soft or hard solid stick (roll-on,roll-up or otherwise), a form that sprays out of a can, and/or the like,but are preferably present in, and administered using, a roll-up, solid,cylindrical-shaped stick, such as the two such sticks that areillustrated in FIG. 1, or a pot.

The base and active agent-containing compositions of the invention havespecific formulations including a unique combination of ingredients, andweight percents thereof which have surprisingly and unexpectedly beendetermined via a significant amount of experimentation and testing onhuman beings over a lengthy period of time to function extremely welltogether, providing topical active agent-containing skin compositionsthat are extremely efficacious for: (i) repairing, improving, partially(less than 100%) or fully (100%) healing, or otherwise treating a widevariety of different skin disorders, diseases, conditions, maladies,severe (or other) dryness and/or the like, of the skin of mammals, whenemployed in the manner, and under the conditions, that are describedherein, including, but not limited to, inflammation, redness, itching,bumps, blisters, cuts, punctures, other wounds, cracking, severedryness, allergic reactions, insect bites, microbes (various types ofbacteria, viruses and/or the like), trauma, irritant dermatitis, contactdermatitis, seborrheic dermatitis, stasis dermatitis, perleche,psoriasis, eczema, eczema craquele, acne excoriee (a form or irritatedand/or picked acne), cheilitis, a variety of different skincomplications resulting from acne, xerosis, disease related skinconditions and dryness from a variety of different medications,including, but not limited to, isotretinoin, acitretin, lipid-loweringagents and/or the like; and/or (ii) causing the skin to feel lesspainful, less irritated, less sore, less itchy, more soothed, moresoftened and/or more conditioned (in comparison with how the skin feltprior to a use of the composition(s)).

The base and active agent-containing compositions of the invention havenumerous very important benefits and advantages in the topical skintreatment field in comparison with other topical compositions forapplication to the skin, which often do not have such benefits andadvantages, including hydrocortisone-containing topical compositions.Extremely advantageously, compositions within the invention typically:

-   -   (i) penetrate one or a plurality of layers of a mammal's skin        including, for example, the epidermis and dermis, and the        tissues present therein, thereby exhibiting efficacious repair,        improvement, healing, treatment and/or other beneficial actions        in connection with a wide variety of different skin disorders,        diseases, adverse conditions and/or the like deep within the        layers and/or tissues of the skin, rather than only resting,        laying or sitting on top of the outside of the outermost layer        of the mammal's skin, as many other topical skin compositions        do;    -   (ii) provide a barrier on the surface of the skin that functions        to seal the surface of the skin off from the outside        environment, and reduce or prevent transepidermal water loss        (TEWL) from the skin, thereby allowing the skin to retain        moisture, and protecting the skin, which may already be damaged,        injured or diseased, from one or a plurality of adverse        environmental and/or other conditions (sun, wind, very high or        very low temperatures, precipitation, dirt, debris, and/or the        like), thereby permitting the skin to be repaired, improve or        fully heal while, at the same time, also preventing further or        additional damage or injury (or other adverse effects) to the        skin;    -   (iii) do not have an undesirable feel to the touch or skin of a        mammal, such as a very thick, very thin, tacky, sticky, greasy        or gritty feel, but rather have a relatively smooth, non-tacky,        non-sticky, non-greasy, non-gritty and desirable feel to the        touch or skin of a mammal;    -   (iv) have no significant taste or odor, or have a pleasant or        desirable taste, with minimal (typically about 20% or less, and        preferably about 10% or less, and more preferably about 5% or        less) or none (0%) of the bitterness, bitter taste or other        unpleasant or undesirable taste that is typically caused by        hydrocortisone and/or other composition ingredients        (particularly active agent(s)), and odor to a user when applied        to mucosal areas of the user's lips and/or elsewhere (i.e., it        typically does not taste or smell bitter or otherwise        unpleasant, and often tastes and smells good as a result of the        base formulation and/or flavorings masking, hiding, reducing or        eliminating the otherwise bitterness, bitter taste and/or smell        and/or other unpleasant taste and/or smell of the hydrocortisone        (and/or other unpleasant tasting and/or smelling active or        inactive ingredient(s)), which is very unusual for        hydrocortisone-containing, and many other active        ingredient-containing, topical skin compositions and products);    -   (v) may be formed into a wide variety of different sizes and/or        shapes, or in multiple sizes and/or shapes (see, for example,        FIG. 1), thereby permitting it to be topically applied to        extremely small and extremely large areas of the skin;    -   (vi) may be applied over various different body surface areas of        widely varying sizes and/or types, for example, in a lip-based        product for application to the lips, and also in a separate        product that is suitable for topical application to larger body        surfaces, and, thus, permit a patient to treat very small and/or        very large areas of the skin, with no limit in size of skin area        to be treated (such as an area that is a size of a pinpoint or        smaller and/or an area spanning one or a plurality of square        inches or larger);    -   (vii) are very convenient and easy to administer and deliver by        users;    -   (viii) are safe for use by human beings, animals and other        mammals;    -   (ix) are reliable for patients and other users with respect to        their healing effects (i.e., patients can expect to observe or        detect an improvement of, or repair in, their skin or a complete        healing thereof, as is discussed herein);    -   (x) preferably, have a relatively solid consistency, being firm,        rigid and/or compact, but preferably pliable, thereby allowing        them to have longevity on the lips and other areas of the body        to which they are topically applied (i.e., they remain on those        portions of the body for relatively long periods of time, and        typically longer periods of time in comparison with other such        products) and a good spreadability (i.e., they easily and        readily spread or slide on, over or across the skin);    -   (xi) do not easily or readily become removed from the skin of a        user (by wiping, patting, rubbing, washing and/or the like)        after being applied topically thereto, rendering them more        likely than products that easily or readily become removed from        the skin to repair, improve or heal the skin for a relatively        long period of time, and to protect the skin from adverse        environmental and/or other conditions, as is discussed above;    -   (xii) maintain their consistency, form and/or shape (and        typically all three) over relatively long periods of time, such        as one or a plurality of months or years, and under relatively        extreme environmental conditions, such as extremely hot and        extremely cold temperatures (i.e., they typically do not melt at        very high temperatures and do not crack at very low        temperatures), thereby rendering them to be extremely versatile        and capable of use at virtually all temperatures, and in        virtually all environmental conditions, in which a user may be        present or encounter;    -   (xiii) remain physically and chemically stable over long periods        of time, such as a plurality of months or years, and, thus,        typically do not deteriorate, disintegrate or otherwise break        down, or the like, over time and produce a “gritty” consistency        (i.e., including a plurality of rough granules) or other        undesirable consistency, as do many other topical skin        compositions and products;    -   (xiv) are cosmetically elegant and physically appealing and        desirable in appearance to consumers;    -   (xv) promote, encourage or otherwise enhance patient compliance        (as a result of the benefits described herein); and/or    -   (xvi) are relatively inexpensive.

Most base and active agent-containing compositions of the inventionpossess each of the above benefits and advantages, rendering them to besignificantly more beneficial and advantageous, and great improvements,in comparison with other known (or other) topical skin compositions andproducts, which typically do not have some or all of such benefits andadvantages, including those that contain hydrocortisone. The base andactive agent-containing compositions of the invention, and relatedmethods, have been determined via a significant amount ofexperimentation and testing on human beings, as is discussed herein, andas is illustrated in FIGS. 2-17, to typically be superior (and often farsuperior) in one or more of the above characteristics (and often in allof these characteristics) in comparison with similar and/or other knownbase and other compositions, including those that containhydrocortisone, in: (i) repairing, improving, healing or otherwisetreating a wide variety of skin disorders, diseases, conditions,maladies, dryness and/or the like; and/or (ii) causing the skin of auser to experience a reduction in pain, soreness, itching or otherdiscomfort or undesirable effect(s) and/or an increase in soothing,softness, conditioning and/or the like. Extremely advantageously, moredesirable, more pronounced and/or more rapid positive results aretypically achieved with the inventive compositions in comparison withother topical skin compositions and products.

Also extremely advantageously, the base and active agent-containingcompositions of the invention generally have an ability to maintainingtheir final form, shape and/or consistency (typically all three ofthem), such as a relatively rigid, firm and compact, but preferablypliable, solid form, preferably in a cylinder (stick) shape under: (i)very high temperatures (i.e., temperatures up to about 50° C. (about122° F.) and, in some cases, even up to about 60° C. (about 140° F.),for example, in the glove box of a 100° F. vehicle during the summermonths in a southern U.S. state; and (ii) very low temperatures, such ason a ski slope in a northern U.S. state during the coldest months of avery cold winter, for example, at temperatures below about 32° F. (0°C.), and even below about 0° F. (−17.7° C.). Thus, in contrast with manyother topical skin compositions, which often melt, decompose,disintegrate, deteriorate, or otherwise break down or fall apart, orhave some other adverse consistency, form and/or shape change, oftencausing them to be or become very messy, sloppy, sticky, greasy, tacky,gritty and/or the like, particularly at relatively high temperatures,the base and active agent-containing compositions of the invention, whenpresent in a solid form, such as a stick, generally will not melt,decompose, disintegrate, deteriorate, or otherwise break down or fallapart, or become messy, sloppy, sticky, greasy, tacky or gritty at theserelatively high temperatures. This renders such base and activeagent-containing compositions of the invention extremely versatile,dependable and reliable. They typically have a melting point rangingfrom about 50° C. to about 60° C. (from about 122° F. to about 140° F.),a congealing point ranging from about 25° C. to about 30° C. (from about77° F. to about 86° F.), and no freezing point and, thus, veryadvantageously, typically have an ability to maintain their form, shapeand consistency under very extreme heat and very extreme coldconditions, rendering them useful at virtually all temperatures andconditions that can be endured by human beings, animals and othermammals, and in a wide variety of climates, seasons and areas of theworld.

Base compositions and active agent-containing compositions within thepresent invention, as well as their methods for production, havecontinuously been experimented with, and improved, over a lengthy periodof time. To date, numerous different formulations have been produced andexperimentally tested. Those formulations that are referred to herein as“original” were some of the initial formulations that were prepared andexperimentally tested, and those formulations that are referred toherein as “subsequent” and/or “improved” are later improved formulationsthat are more preferred than the original formulations. The methods forproduction of these improved formulations, which are described herein indetail, are also more preferred.

The improved formulations of the invention have been determined, via atremendous amount of experimentation over a lengthy period of time, tohave an improved (enhanced, easier and better) slip (spreadability) onthe skin of human beings, in comparison with the original formulations,permitting them to slide and spread on the skin more easily and rapidly,and coat the skin more fully and with more formulation, regardless oftheir size or containment device (jar, pot, can, squeezable tube, rigidtube, or the like), reducing, and typically completely eliminating, any“skip” areas of the skin (areas of the skin to be treated or coated withthe compositions that mistakenly or inappropriately do not become coatedwith the compositions, or do not have any of the compositions appliedthereto), thereby providing a greater quantity of the compositions to beapplied to the skin, and a deeper absorption by, and penetration into,the various layers of the skin by the compositions, and improved patientcompliance with respect to their use of the compositions. These are allare very beneficial characteristic for topically applied skincompositions, and significant advantages and improvements in comparisonwith known topical skin compositions (both over-the-counter andprescription).

Additionally, the improved formulations of the invention have animproved (enhanced or better) taste, smell and/or texture (typically allthree) in comparison with the original formulations, even when they donot include one or more flavoring ingredients (as well as when they do),and when they include hydrocortisone. All of these compositionstypically have a better taste and smell in comparison with knownformulations including hydrocortisone, such as CortiBalm lip balm(Milan, Ind.), and other known formulations, which improves, promotesand encourages patient compliance. (Some active (or other) agentsemployed in topical skin compositions, for example, hydrocortisone, areknown to produce or have an unpleasant taste and/or smell, renderingthem undesirable for patients or other users to apply to their mouth orface (or to other areas of their bodies).)

Further, when present, or contained, in a pot or jar, users of theoriginal formulations of the invention typically need to use theirfingernails to scrape the formulations out of the pot or jar. Users donot need to do this with the improved formulations of the invention,which is a benefit of these improved formulations in comparison with theoriginal formations.

Moreover, the improved formulations of the invention may be used, andapplied, more easily in “cold temperature” situations and environmentsin comparison with the original formulations.

All base compositions and active agent-containing compositions of theinvention can be produced in a manner that include, or do not include,one or more flavoring ingredients, and that may be contained in a widevariety of different containers, such as a squeezable or non-squeezabletube, a pot, a jar, a can and/or the like, and in a solid, semi-solid orother form, such as a small or large solid stick.

The various ingredients present in the base compositions and activeagent-containing compositions of the present invention, includinghydrocortisone-containing compositions, and related methods ofproduction and use, are described in detail hereinbelow. They preferablydo not include any petroleum jelly (petrolatum), and if they do, theamount of the petroleum jelly is generally in small quantities,generally less than about 5% by weight, and more preferably less thanabout 4% by weight, and still more preferably less than about 3% byweight, and still more preferably less than about 2% by weight, and evenmore preferably less than about 1% by weight, and most preferably 0% byweight. They also preferably do not include any water, surfactants,emulsifiers, lidocaine hydrochloride, propylene glycol, aluminumfluoride (or combinations of aluminum and fluoride) or retinol (orretinol derivatives or extracts). If they do include any of theforegoing ingredients, each such ingredient is only generally present invery small quantities, generally less than about 2.5% by weight, andmore preferably less than about 2% by weight, and still more preferablyless than about 1.5% by weight, and still more preferably less thanabout 1% by weight, and even more preferably less than about 0.5% byweight, and most preferably 0% by weight.

Hydrocortisone (and/or one or more other active agents) functions as anactive agent in the active agent-containing compositions of theinvention, and the other ingredients present therein typicallycollectively form a base, which functions as a topical skin carriervehicle for the hydrocortisone (and/or other active agents) to betopically applied to the skin of a human being, animal or other mammal.Most or all of the components of the inventive base formulation functiontogether as a blend to bind the various components in the hydrocortisone(and/or other active agent-containing) formulation together in a mannerthat enables it to be easily, readily, smoothly and properly topicallyapplied to the skin of a mammal, and to penetrate one or a plurality oflayers of the skin (usually several or all of them), and/or one or moreof the tissues present therein. This permits the hydrocortisone (and/orother active agent) to exhibit its healing and/or other beneficialeffects internally and deeply within the structure of the skin, and insignificantly deeper areas, tissues and/or layers of the skin than onlythe top layer (rather than only sitting, resting or laying on theoutermost area of the outermost layer of the skin, with no or littlepenetrating action, as is the case with many other topical skincompositions, including those containing hydrocortisone). As a result,extremely advantageously, the hydrocortisone (and/or other active agent)becomes absorbed and/or adsorbed deep into the various layers andtissues present in the skin of a mammal to a significantly greaterand/or deeper extent, and repairs, improves, heals and/or exhibits otherbeneficial effects in connection with, one or a plurality of internallayers of, and/or tissues present in, the skin (as well as various areasof the uppermost, external, layer of the skin) in a significantlygreater extent, in comparison with other hydrocortisone- or activeagent-containing topical skin compositions, thereby promoting, andgenerally providing, excellent skin repair, improvement, treatmentand/or healing results.

Via a significant amount of experimentation and testing with the variousingredients of the base compositions of the invention, and with thehydrocortisone-containing and other compositions of the invention, itwas determined to be extremely difficult to cause, or have, theingredients thereof mix together properly, become evenly distributedwithin the compositions, and form compositions having the beneficialcharacteristics that are described herein. As one example, it was foundto be extremely difficult to include the ingredient Natunola Castor 1023in the compositions along with the other ingredients present therein ina form of a solid, such as a soft or hard stick, and still have thesolid possess one or all of the characteristics that are discussedherein, including an ability of the hydrocortisone (and/or other activeagents) present therein to penetrate one or a plurality of the layersof, and/or tissues in, a mammal's skin, and generally be efficacious,and maintain its final form and shape, even when present in extremeenvironmental conditions, such as freezing, or elevated temperatures,and conditions in which users may carry them on their person, or closeto their bodies, and exposed to body heat.

As a result of the above, it was eventually determined that the basecompositions and hydrocortisone- (and/or other active agent-) containingcompositions typically should include the ingredients that are describedherein at the weight percents indicated. When these compositions wereproduced without one or more of the required ingredients and/or usingdifferent weight percents thereof, often a very undesirable productresulted, which did not have component ingredients evenly distributedtherein, which could not properly be applied to the skin of a humanbeing, animal or other mammal, which would not penetrate one or aplurality of layers and/or tissues of the skin, which did not have anability to maintain its shape and/or form under adverse environmentalconditions, and/or which did not have one or more of the otherbeneficial characteristics that are described herein.

Base Composition

The novel base compositions that are described herein, which may beemployed with hydrocortisone as an active agent, or with one or aplurality of additional and/or different active ingredients, havesurprisingly and unexpectedly been determined via a significant amountof testing and experimentation over a lengthy period of time to beparticularly effective as a carrier vehicle for topically applied activeagents, such as hydrocortisone (and many other active agents). Itsunique formulation of ingredients, and particular weight percentsthereof in the formulation, has been found to be particularly effectivein promoting or causing a penetration of the active agents(s), alongwith the base composition, deep within one or more of the various layersand tissues of the skin, including the dermis and epidermis, andmaintaining their consistency, form and/or shape (usually all three),such as a solid stick, during extreme environmental conditions, such asextreme heat or cold. Many other base formulations verydisadvantageously tend to melt and become liquid-like, messy and/orsloppy during relatively high temperature conditions, such as when leftin a hot car during summer months, potentially staining clothing andcausing jewelry and other objects to become greasy and/or dirty. Thesenovel base compositions have been determined to be significantly moreeffective for a topical delivery to the skin of humans beings, animalsand/or other mammals of one or a plurality of active agents incomparison with other topically applied skin bases.

The amounts of the various ingredients present in the base compositionsof the invention may vary widely, depending upon a variety of factors,such as the particular form and shape that the final topical formulation(including one or more active agents) will have, for example, a solidform, such as a soft or hard stick, a gel, a cream, an ointment and/orthe like, the number and types of base ingredients that are employed,the number and types of active agents that are to be employed, and/orthe like, and may be determined by those having ordinary skill in theart using the information that is provided herein.

The base formulations of the invention (both original and improved)include FANCOL VB, Natunola Castor 1023, Finsolv TN and bees wax, andoptionally one or a plurality of plant oils, fatty alcohols, fats andflavorings, each in amounts that are effective for forming a base havingan ability to act effectively as a topical carrier vehicle upon the skinor human beings, animals and/or other mammals for one or more activeagents, such as hydrocortisone, preferably in a form of a solid, such asa stick, or semi-solid, and possessing one or more (or all) of thebeneficial characteristics that are described herein. In the improvedbase formulations (and active-agent formulations), it is preferred thatthe base formulations include one or more plant oils, one or more fattyalcohols and one or more fats, as is discussed herein. Although each ofthe base ingredients is discussed in greater detail hereinbelow withrespect to the compositions of the invention that include one or moreactive agents, their weight percents in the base compositions of theinvention are described directly below.

FANCOL VB

The amount of FANCOL VB that is present in the base compositions is anamount that is effective to cause the base compositions to have one ormore of the beneficial characteristics that are described herein, suchas causing, or aiding in causing (generally in combination with one ormore other ingredients), such base compositions to properly form, or bepresent in a form of, a solid or semi-solid structure, for example, inthe shape of a stick, or any another shape desired or required, orpresent in a pot or jar.

Original Base Compositions

When none of the above-described optional base ingredients is present inthe original base compositions, the amount of FANCOL VB that is presentin the base compositions preferably ranges from about 13 to about 25weight percent, and more preferably ranges from about 16 to about 22weight percent (with the total base compositions having 100 percentweight). When, however, one or more of such optional base ingredients ispresent in the original base compositions, the amount of FANCOL VB thatis present therein may be much less, such as about 9 weight percent (orpossibly even lower, depending upon the number of optional baseingredients included in the base compositions, and the weight percentsthereof), and preferably ranges from about 9 to about 13 weight percent,and more preferably ranges from about 10 to about 12 weight percent.

Improved Base Compositions

The amount of FANCOL VB that is present in the improved basecompositions of the invention preferably ranges from about 6 to about 25weight percent, and more preferably ranges from about 6 to about 16weight percent, and still more preferably ranges from about 10 to about12 weight percent, and is most preferably about 11 weight percent(whether or not any favoring ingredients are present in the basecompositions).

Natunola Castor 1023

The amount of Natunola Castor 1023 that is present in the basecompositions is an amount that is effective to cause the basecompositions to have one or more of the beneficial characteristics thatare described herein, such as causing, or aiding in causing (generallyin combination with one or more other ingredients), such basecompositions to properly form, or be present in a form of, a solidstructure, or semi-solid structure, for example, in the shape of astick, or any another shape desired or required, or present in a pot orjar.

Original Base Compositions

When none of the above-described optional base ingredients is present inthe original base compositions, the amount of Natunola Castor 1023 thatis present in the original base compositions preferably ranges fromabout 23 to about 39 weight percent, and more preferably ranges fromabout 26 to about 35 weight percent (with the total base compositionshaving 100 percent weight). When, however, one or more of such optionalbase ingredients is present in the base compositions, the amount ofNatunola Castor 1023 that is present therein may be much less, such asabout 16 weight percent (or possibly even lower, depending upon thenumber of optional base ingredients included in the base compositions,and the weight percents thereof), and preferably ranges from about 16 toabout 20 weight percent, and more preferably ranges from about 17 toabout 19 weight percent.

Improved Base Compositions

The amount of Natunola Castor 1023 that is present in the improved basecompositions of the invention preferably ranges from about 5 to about 39weight percent, and more preferably ranges from about 5 to about 15weight percent, and still more preferably ranges from about 9 to about11 weight percent, and is most preferably about 10 weight percent(whether or not any favoring ingredients are present in the basecompositions).

Finsolv TN

The amount of Finsolv TN that is present in the base compositions is anamount that is effective to cause the base compositions to have one ormore of the beneficial characteristics that are described herein, suchas causing, or aiding in causing (possibly in combination with one ormore other ingredients), such base compositions to function as anemollient upon the skin (i.e., to render or make the skin softer than itwould have been prior to applying the base compositions thereto).

Original Base Compositions

When none of the above-described optional base ingredients is present inthe original base compositions, the amount of Finsolv TN that is presentin the original base compositions preferably ranges from about 13 toabout 25 weight percent, and more preferably ranges from about 16 toabout 22 weight percent (with the total base compositions having 100percent weight). When, however, one or more of such optional baseingredients is present in the base compositions, the amount of FinsolvTN that is present therein may be much less, such as about 9 weightpercent (or possibly even lower, depending upon the number of optionalbase ingredients included in the base compositions, and the weightpercents thereof), and preferably ranges from about 9 to about 13 weightpercent, and more preferably ranges from about 10 to about 12 weightpercent.

Improved Base Compositions

The amount of Finsolv TN that is present in the improved basecompositions of the invention preferably ranges from about 9 to about 25weight percent, and more preferably ranges from about 10 to about 20weight percent, and still more preferably ranges from about 14 to about16 weight percent, and is most preferably about 15 weight percent(whether or not any favoring ingredients are present in the basecompositions).

Bees Wax

The amount of bees wax that is present in the base compositions is anamount that is effective to cause the base compositions to have one ormore of the beneficial characteristics that are described herein, suchas causing, or aiding in causing (generally in combination with one ormore other ingredients), such base compositions to properly form, or bepresent in a form of, a solid structure, or semi-solid structure, forexample, in the shape of a stick, or any another shape desired orrequired, or present in a pot or jar.

Original Base Compositions

When none of the above-described optional base ingredients is present inthe original base compositions, the amount of bees wax that is presentin the original base compositions preferably ranges from about 26 toabout 43 weight percent, and more preferably ranges from about 29 toabout 39 weight percent (with the total base compositions having 100percent weight). When, however, one or more of such optional baseingredients is present in the base compositions, the amount of bees waxthat is present therein may be much less, such as about 18 weightpercent (or possibly even lower, depending upon the number of optionalbase ingredients included in the base compositions, and the weightpercents thereof), and preferably ranges from about 18 to about 22weight percent, and more preferably ranges from about 19 to about 21weight percent.

Improved Base Compositions

The amount of bees wax that is present in the improved base compositionsof the invention preferably ranges from about 6 to about 43 weightpercent, and more preferably ranges from about 6 to about 16 weightpercent, and still more preferably ranges from about 10 to about 12weight percent, and is most preferably about 11 weight percent (whetheror not any favoring ingredients are present in the base compositions).

When only FANCOL VB, Natunola Castor 1023, Finsolv TN and bees wax arepresent in the base composition, and it is desired to form a solid stickform of the base composition as a topical carrier vehicle for one ormore active ingredients, preferred base compositions of the inventionincludes the weight percents identified below (out of 100 weight percentfor the total base) for these four ingredients.

Ingredient Weight Percent FANCOL VB 18.333 Natunola Castor 1023 30.000Finsolv TN 18.333 Bees Wax 33.334 TOTAL 100

The original and improved base formulations of the present inventionoptionally (i.e., the weight percent may be 0%), but preferably, alsoinclude one or a plurality of plant and/or plant seed oils, such ascastor oil, one or a plurality of fatty alcohols, such as stearylalcohol, one or a plurality of fats, such as cocoa butter, and/or one ora plurality of flavorings, such as vanilla flavoring (and preferably allof them). They, and the compositions of the invention that include oneor more active ingredients, may also optionally include a variety ofother ingredients, as is discussed hereinbelow.

Plant and Plant Seed Oils

The amount (combined) of one or more plant oils or plant seed oils thatare present in the base compositions is an amount that is effective tocause the base compositions to have one or more of the beneficialcharacteristics that are described herein, such as causing, or aiding incausing (possibly in combination with one or more other ingredients),such base compositions to function as an emollient upon the skin (i.e.,to render the skin softer than it would have been prior to applying thebase compositions thereto).

Original Base Compositions

When present in the original base compositions, the plant oil(s) and/orplant seed oil(s), such as castor oil, preferably is present in the basecompositions in an amount (combined) preferably ranging from about 0.1to about 24 weight percent, and more preferably ranging from about 8 toabout 17 weight percent, and most preferably ranging from about 10 toabout 15 weight percent.

Improved Base Compositions

When present in the improved base compositions, the plant oil(s) and/orplant seed oil(s), such as castor oil, preferably is present in the basecompositions in an amount (combined) preferably ranging from about 0.1to about 38.5 (from about 0.1 to about 38.0 if one or more flavoringingredients are present) weight percent, and more preferably rangingfrom about 13.5 to about 38.5 (from about 13 to about 38 if one or moreflavoring ingredients are present) weight percent, and still morepreferably ranging from about 25 to about 27 (from about 24.50 to about26.50 if one or more flavoring ingredients are present), and is mostpreferably about 26 (about 25.5 if one or more flavoring ingredients arepresent) weight percent.

Fatty Alcohols

The amount (combined) of one or more fatty alcohols that is present inthe base compositions is an amount that is effective to cause the basecompositions to have one or more of the beneficial characteristics thatare described herein, such as causing, or aiding in causing (generallyin combination with one or more other ingredients), such basecompositions to properly form, or be present in a form of, a solidstructure, or semi-solid structure, for example, in the shape of astick, or any another shape desired or required, or present in a pot orjar.

Original Base Compositions

When present in the original base compositions, the fatty alcohol(s),such as stearyl alcohol, preferably is present in the base compositionsin an amount (combined) preferably ranging from about 0.1 to about 22weight percent, and more preferably ranging from about 10 to about 22weight percent, and most preferably ranging from about 18 to about 22weight percent.

Improved Base Compositions

When present in the improved base compositions, the fatty alcohol(s),such as stearyl alcohol, preferably is present in the base compositionsin an amount (combined) preferably ranging from about 0.1 to about 25weight percent, and more preferably ranging from about 15 to about 25weight percent, and still more preferably ranging from about 19 to about21 weight percent, and is most preferably about 20 weight percent(whether or not any favoring ingredients are present in the basecompositions).

Fats

The amount (combined) of one or more fats that is present in the basecompositions is an amount that is effective to cause the basecompositions to have one or more of the beneficial characteristics thatare described herein, such as causing, or aiding in causing (generallyin combination with one or more other ingredients), such basecompositions to properly form, or be present in a form of, a solidstructure, or semi-solid structure, for example, in the shape of astick, or any another shape desired or required, or present in a pot orjar.

Original Base Compositions

When present in the original base compositions, the fat(s), such ascocoa butter, is preferably present in the base compositions in anamount (combined) preferably ranging from about 0.1 to about 9 weightpercent, and more preferably ranging from about 4 to about 9 weightpercent, and most preferably ranging from about 6 to about 8 weightpercent.

Improved Base Compositions

When present in the improved base compositions, the fat(s), such ascocoa butter, preferably is present in the base compositions in anamount (combined) preferably ranging from about 0.1 to about 12 weightpercent, and more preferably ranging from about 2 to about 12 weightpercent, and still more preferably ranging from about 6 to about 8weight percent, and is most preferably about 7 weight percent (whetheror not any favoring ingredients are present in the base compositions).

Flavorings

The amount (combined) of one or more flavorings that is present in thebase compositions is an amount that is effective to cause the basecompositions to: (i) have a pleasant or desirable, or a specific, tasteand/or odor, such as a good vanilla taste and odor; (ii) have no, areduced, or a minimal, unpleasant taste and/or odor (in comparison withhow the taste and/or odor would have been if no flavoring(s) had beenadded); or (iii) have no taste and/or no odor.

Original Base Compositions

When present in the original base compositions, the flavoring(s), suchas vanilla flavorings, are present in an amount (combined) preferablyranging from about 0.1 to about 3.5 weight percent, and more preferablyranging from about 0.2 to about 3 weight percent, and most preferablyranging from about 0.4 to about 1 weight percent.

Improved Base Compositions

When present in the improved base compositions, the flavoring(s), suchas vanilla flavorings, preferably is present in the base compositions inan amount (combined) preferably ranging from about 0.1 to about 3.5weight percent, and more preferably ranging from about 0.1 to about 2.5weight percent, and still more preferably ranging from about 0.3 toabout 1.5 weight percent, and is most preferably about 0.5 weightpercent.

The inventive base compositions are described herein as a carriervehicle for hydrocortisone, but may be used with a wide variety ofother, or additional, topically applied active agents, such as aredescribed herein.

Typically, one or a plurality of active agents will be combined with thebase to form a composition for a topical application to the skin of amammal in a combined weight percent (of the total weight of thecompositions) that is effective for treating, healing (partially orfully) and/or repairing the skin of mammals with respect to a widevariety of different disorders, diseases and/or conditions, such asthose that are described herein, or others, and/or causing the skin tofeel more soothed, softened and/or conditioned that in did prior to ause of the active agent-containing compositions. The base composition(combination of base ingredients) will typically form the remainingweight percent of the composition.

The amount of a base composition of the invention that is included in atopical active-agent containing skin formulation of the invention mayvary widely, depending upon a variety of factors, such as the age,gender, weight and condition of the patient being treated, the medicalproblem presented by the patient being treated, the particular activeagent(s) to be included in the formulation, whether the patient has anyadditional medical problems or concerns, and/or the like. The amount ofthe base composition employed is preferably an amount that is effectivefor acting as a topically applied skin carrier vehicle for the one ormore active agents. Such amount will generally be 100 weight percent(total weight of the composition) minus the total weight percent of thecombined active agent(s), and typically ranges from about 80 to about99.9 weight percent, based upon the total weight of the compositions.Such an amount preferably ranges from about 95 to about 99.9 weightpercent, more preferably ranges from about 97 to about 99 weight percentand most preferably ranges from about 98 to about 99 weight percent. Theamounts of the various ingredients that may be present in the basecomposition may vary widely depending upon a variety of factors, such asthe number of ingredients that are employed, the type of ingredientsthat are employed and the like, and may readily be determined by thosehaving ordinary skill in the art.

Three preferred base composition of the invention that may be employedwith one or a plurality of active agents, such as hydrocortisone, forforming a solid form thereof, such as a stick, and in the methods of theinvention, contains the components that are set forth below, and theexact or approximate concentrations thereof (out of 100 weight percentfor the total base). The first two base compositions include a flavoring(vanilla) and the third one does not.

Original Base Compositions

Ingredient Weight Percent FANCOL VB 11.111 Natunola Castor 1023 18.181FINSOLV TN 11.111 Bees Wax 20.202 Castor Oil 11.616 Stearyl Alcohol20.202 Cocoa Butter 7.070 Flavor 0.513 TOTAL 100

Ingredient Weight Percent FANCOL VB 11 Natunola Castor 1023 18 FINSOLVTN 11 Bees Wax 20 Castor Oil 12.5 Stearyl Alcohol 20 Cocoa Butter 7Flavoring 0.5 TOTAL 100

Ingredient Weight Percent FANCOL VB 11 Natunola Castor 1023 18 FINSOLVTN 11 Bees Wax 20 Castor Oil 13 Stearyl Alcohol 20 Cocoa Butter 7 TOTAL100

Improved Base Compositions

Ingredient Weight Percent FANCOL VB 11.00 Natunola Castor 1023 10.00FINSOLV TN 15.00 Bees Wax 11.00 Castor Oil 25.50 Stearyl Alcohol 20.00Cocoa Butter 7.00 Flavoring (Vanilla) 0.50 TOTAL 100

Ingredient Weight Percent FANCOL VB 11.00 Natunola Castor 1023 10.00FINSOLV TN 15.00 Bees Wax 11.00 Castor Oil 26.00 Stearyl Alcohol 20.00Cocoa Butter 7.00 Flavoring (Vanilla) 0.00 TOTAL 100

Compositions Including Active Agent(s)

The various ingredients of compositions within the invention thatinclude one or a plurality of active agents, such as hydrocortisone,alone or in combination with one or more other active agents, the weightpercents thereof, and preferred compositions of the invention, arediscussed below.

Hydrocortisone and/or other Active Ingredients)

Hydrocortisone (also known as Cortisol) is employed in topicalcompositions within the invention as an active agent to repair(partially—from more than 0% to less than 100%, and preferablyfully—about 100%), improve, heal (partially—from more than 0% to lessthan 100%, and preferably fully—about 100%) and/or treat the variousskin disorders, diseases and adverse conditions that are describedherein, as well as others, and/or to cause the skin to feel moresoothed, softened and/or conditioned than prior to a use of the activeagent, either as a sole active agent or alone, or in combination, withone or a plurality of other active ingredients, and either in a pureform or in one or more various known (or other) synthetic, derivative orcombination forms, which are known by those having ordinary skill in theart. These forms of hydrocortisone are known under the umbrella of“topical corticosteroids,” and have different strengths andformulations, as are known by those having ordinary skill in the art.Many of them are pharmaceutical grade products. Hydrocortisone is, atpresent, typically only available as a lotion, cream, ointment and inone semi-solid balm product that is specifically designed, and marketedfor, the lips.

Hydrocortisone ((11β)-11,17,21-trihydroxypregn-4-ene-3,20-dione) has thechemical formula C₂₁H₃₀O₅, and the chemical structure that is shownbelow, and is the primary steroid hormone or glucocorticoid that isproduced by the adrenal cortex of the adrenal gland.

Hydrocortisone is generally released by the body in response to stressand to a low level of blood glucocorticoids, and its primary functionsare to suppress the immune system, increase blood sugar throughgluconeogenesis and aid in fat, protein and carbohydrate metabolism.

Various synthetic and other forms of hydrocortisone may be used to treata variety of different disorders, diseases, adverse conditions and/orillnesses, either as an injection or topically, for example, in atreatment of inflammation, redness, allergy, itching, collagen diseases,asthma, adrenocortical deficiency, shock, and some neoplasticconditions.

When applied topically to the skin, hydrocortisone often reduces orterminates the actions of various chemicals in the bodies of human andnon-human mammals that cause inflammation, redness, swelling, blisters,itching and/or the like. It is useful for treating and healing one or aplurality of disorders of the skin, which may be caused by a number ofdifferent conditions or factors, including, but not limited to, a widevariety of skin inflammatory conditions, redness, swelling, blisters,burns, cuts, punctures (and other skin perforations), bug bites, razorbumps, chronic (or other) dermatitis, irritant dermatitis, contactdermatitis, seborrheic dermatitis, stasis dermatitis, acne excoriee,many skin complications resulting from acne, allergic reactions, insectbites, trauma, perleche, eczema, eczema craquele, psoriasis, xerosis,genital skin disorders, poison ivy, poison oak, general itching, apresence of microbes (bacteria, viruses, and/or the like), diseaserelated skin conditions and dryness from medications such asisotretinoin, acitretin and lipid lowering agents, and/or the like.

Hydrocortisone USP (United States Pharmacopeia), and other forms ofhydrocortisone, are commercially available from sources that are knownby those having ordinary skill in the art, for example, from SpectrumChemical Mfg. Corp. (Gardena, Calif.) and Pfizer CentreSource(Kalamazoo, Mich.).

The amount (combined) of the one or more active agents, such ashydrocortisone (alone or in combination with one or more other activeagents), that may be employed in the active agent-compositions of thepresent invention is an amount that is effective, when present in a basecomposition described herein, to promote, encourage or cause a partialor total repair, improvement, healing, treatment or other beneficialeffect in connection with a skin disorder, disease, adverse condition,malady and/or the like, as they are discussed herein in detail (orotherwise). The amount (combined) of the one or more active agents thatis preferably incorporated into, or otherwise formulated with, the basecompositions of the invention will generally be 100 weight percent(total weight of the composition) minus the total weight percent of thebase composition (including all ingredients, and combined amountsthereof, employed in the base composition). For the originalactive-agent containing compositions of the invention, such an amountpreferably ranges from about 0.1 to about 5 weight percent, based uponthe total weight of the compositions, and more preferably ranges fromabout 0.5 to about 3 weight percent, and even more preferably rangesfrom about 0.8 to about 2 weight percent, and most preferably is about 1weight percent. For the improved active-agent containing compositions ofthe invention, such an amount preferably ranges from about 0.1 to about5 weight percent, based upon the total weight of the compositions, andmore preferably ranges from about 0.5 to about 3 weight percent, andeven more preferably ranges from about 0.8 to about 2 weight percent,and still more preferably ranges from about 0.9 to about 1.5 weightpercent, and even more preferably ranges from about 0.95 to about 1.2weight percent, and most preferably is about 1.0 weight percent.

Additional information about hydrocortisone and/or its uses is presentin Hydrocortisone—A Medical Dictionary, Bibliography and AnnotatedResearch Guide to Internet References (ICON Health Publications,ISBN-10: 0497005581, 2004); Hydrocortisone: Webster's Timeline History,1950-2007 (ICON Group International, Inc., ASIN: B003N2QNFS, 2010);Hydrocortisone and Cortisone (Merck & Co., ASIN: B000GSVX48, 1956); andFrancis D. W. Lukins, Medical Uses of Cortisone including Hydrocortisoneand Corticotropin (The Blakiston Company, ASIN: B000SAR10W, 1954).

One or a plurality of a wide variety of topical active ingredients otherthan hydrocortisone, or in addition to hydrocortisone, alone or in acombination with one or more other active agents, such as one or aplurality of steroids other than hydrocortisone, antibiotics,antifungals, antihistamines, anti-inflammatories, local anesthetics,anti-itch agents and/or the like, may alternately, or additionally, beincluded in the active-agent containing topical compositions of theinvention, and produced in the manner described herein, to treat,repair, improve and/or heal (fully or partially) a same or similar, ordifferent, skin disease, disorder, condition and/or the like, and/or toprovide one or a plurality of other (different) beneficial effects tothe skin of a human being, animal and/or other mammal. These activeingredients include, but are not limited to, clindamycin (topicalantibiotic), erythromycin (topical antibiotic), neomycin (topicalantibiotic), tretinoin (topical retinoid), doxepin (topicalantihistamine), flurandrenolide (topical corticosteroid), terbinafine(topical antifungal), permethrin (insecticide), malathion (insecticide),silver sulfadiazine (antiseptic), salicyclic acid (keratolytic), andvarious herbal agents. The foregoing are only a few examples of thenumerous different active agents that may be employed in thecompositions of the invention, alone or in combination. Such activeingredients are known by those having ordinary skill in the art, andalso are described in sources that are known by those having ordinaryskill in the art, such as in Maryadele J. O'Neil, The Merck Index, anEncyclopedia of Chemicals, Drugs and Biologicals (Merck, 14th Edition,ISBN 091191000X, 2006) and in PDR: The Physician's Desk Reference 2010(PDR Network, LLC, ISBN-10: 1563637480, 2009).

Active ingredients that may be employed with, or in, the basecompositions of the invention, and in the active agent-containingcompositions of the invention, include, but are not limited to, thosethat are identified below, and those that may be invented, developedand/or produced in the future, alone or in any combination (includingall of the various and/or alternative chemical, brand, trade, genericand/or other names that are, or may be, employed to identify each activeingredient, which are known by those having ordinary skill in the art).Sources for these active ingredients are described herein and are knownby those having ordinary skill in the art.

Topical Steroids

-   -   Clobetasol propionate 0.05% (Dermovate)    -   Betamethasone dipropionate 0.25% (Diprolene)    -   Halobetasol proprionate 0.05% (Ultravate)    -   Diflorasone diacetate 0.05% (Psorcon)    -   Fluocinonide 0.05% (Lidex)    -   Halcinonide 0.05% (Halog)    -   Amcinonide 0.05% (Cyclocort)    -   Desoximetasone 0.25% (Topicort)    -   Triamcinolone acetonide 0.5% (Kenalog, Aristocort cream)    -   Mometasone furoate 0.1% (Elocon ointment)    -   Fluticasone propionate 0.005% (Cutivate)    -   Betamethasone dipropionate 0.05% (Diprosone)    -   Fluocinolone acetonide 0.01-0.2% (Synalar, Synemol, Fluonid)    -   Hydrocortisone valerate 0.2% (Westcort)    -   Hydrocortisone butyrate 0.1% (Locoid)    -   Flurandrenolide 0.05% (Cordran)    -   Triamcinolone acetonide 0.1% (Kenalog, Aristocort A ointment)    -   Mometasone furoate 0.1% (Elocon cream, lotion)    -   Triamcinolone acetonide 0.1% (Kenalog, Aristocort cream, lotion)    -   Fluticasone propionate 0.05% (Cutivate cream)    -   Desonide 0.05% (Tridesilon, DesOwen ointment)    -   Fluocinolone acetonide 0.025% (Synalar, Synemol cream)    -   Hydrocortisone valerate 0.2% (Westcort cream)    -   Prednicarbate 0.05% (Aclovate cream, ointment)    -   Triamcinolone acetonide 0.025% (Aristocort A cream, Kenalog        lotion)    -   Fluocinolone acetonide 0.01% (Capex shampoo, Dermasmooth)    -   Desonide 0.05% (DesOwen cream, lotion)    -   Hydrocortisone 2.5% (Hytone cream, lotion, ointment)    -   Hydrocortisone 1%

Topical Antibiotics/Anti-Infectives

-   -   Topical erythromycin (ATS and others)    -   Topical mupirocin (Bactroban)    -   Topical retapamulin (Altabax)    -   Topical bacitracin/polymyxin B (Polysporin)    -   Topical bacitracin/neomycin/polymyxin B (Neosporin)    -   Topical sulfacetamide sodium/urea (Sulfa drugs)

Topical Antifungals

-   -   Natamycin    -   Rimocidin    -   Filipin    -   Nystatin    -   Amphotericin B    -   Candicin    -   Hamycin    -   Miconazole, miconazole nitrate (Micatin)    -   Ketoconazole (Nizoral, Sebizole)    -   Clotrimazole (Lotriminm, Lotrimin AF, Canesten)    -   Econazole    -   Bifonazole    -   Butoconazole    -   Fenticonazole    -   Isoconazole    -   Oxiconazole    -   Sertaconazole (Ertaczo)    -   Sulconazole    -   Tioconazole    -   Fluconazole    -   Itraconazole    -   Isavuconazole    -   Ravuconazole    -   Posaconazole    -   Voriconazole    -   Terconazole    -   Abafungin    -   Terbinafine (Lamisil)    -   Naftifine (Naftin)    -   Butenafine (Lotrimin Ultra)    -   Anidulafungin    -   Caspofungin    -   Micafungin    -   Polygodial    -   Ciclopirox, ciclopirox olamine    -   Tolnaftate (Tinactin, Desenex, Aftate)    -   Undecylenic acid    -   Flucytosine, 5-fluorocytosine    -   Griseofulvin    -   Haloprogin    -   Sodium bicarbonate

Topical Immunomodulators

-   -   Pimecrolimus 1% Cream (Elidel)    -   Tacrolimus 0.1% ointment (Protopic)

Topical Antihistamines

-   -   Clemastine    -   Diphenhydramine (Benadryl)    -   Doxylamine    -   Loratadine    -   Desloratadine    -   Fexofenadine    -   Pheniramine    -   Cetirizine    -   Ebastine    -   Promethazine    -   Chlorpheniramine    -   Levocetirizine    -   Olopatadine    -   Quetiapine    -   Meclizine    -   Dimenhydrinate    -   embramine    -   dimethindene    -   dexchlorpheniramine    -   Vitamin C (Ascorbic acid)    -   Cimetidine    -   Famotidine    -   Ranitidine    -   Nizatidine    -   Roxatidine    -   Lafutidine    -   A-349,821    -   ABT-239    -   Ciproxifan    -   Clobenpropit    -   Thioperamide    -   Thioperamide    -   JNJ 7777120    -   VUF-6002    -   Cromoglicate (Cromolyn)    -   Nedocromil    -   β2 adrenergic agonists        Topical Analgesics    -   Acetaminophen (Tylenol)    -   Diclofenac (Cataflam, Voltaren)    -   Diflunisal (Dolobid)    -   Etodolac (Lodine, Lodine XL)    -   Fenoprofen (Nalfon)    -   Flurbiprofen (Ansaid)    -   Ibuprofen (Advil, Cramp End, Dolgesic, Excedrin IB, Genpril,        Haltran, Ibren, Ibu, Ibuprin, Ibuprohm, Ibu-Tab, Medipren, Midol        IB, Motrin, Nuprin, Pamprin-IB, Q-Profen, Rufen, Trendar)    -   Indomethacin (Indocin, Indocin SR)    -   Ketoprofen (Actron, Orudis, Oruvail)    -   Ketorolac (Toradol)    -   Meclofenamate (Meclomen)    -   Mefenamic Acid (Ponstel)    -   Meloxicam (Mobic)    -   Nabumetone (Relafen)    -   Naproxen (Aleve, Anaprox, Anaprox DS, EC-Naprosyn, Naprelan,        Naprosyn)    -   Oxaprozin (Daypro)    -   Phenylbutazone (Cotylbutazone)    -   Piroxicam (Feldene)    -   Sulindac (Clinoril)    -   Tolmetin (Tolectin, Tolectin DS)    -   Celecoxib (Celebrex)    -   Buprenorphine (Buprenex)    -   Butorphanol (Stadol)    -   Codeine    -   Hydrocodone    -   Hydromorphone (Dilaudid, Dilaudid-5, Dilaudid-HP, Hydrostat IR)    -   Levorphanol (Levo-Dromoran)    -   Meperidine (Demerol)    -   Methadone (Dolophine, Methadose)    -   Morphine (Astramorph PF, AVINZA, Duramorph, Kadian, M S Contin,        MSIR, Oramorph SR, Rescudose, Roxanol)    -   Nalbuphine (Nubain)    -   Oxycodone (OxyContin, Roxicodone)    -   Oxymorphone (Numorphan)    -   Pentazocine (Talwin)    -   Propoxyphene (Cotanal-65, Darvon)    -   Tramadol (Ultram)    -   Tramadol and Acetaminophen (Ultracet)    -   Butalbital, Acetaminophen, and Caffeine (Femcet, Fioricet,        Esgic, Esgic-Plus)    -   Butalbital, Aspirin, and Caffeine (Fiorinal)    -   Butalbital, acetaminophen, caffeine, and codeine (Fioricet with        Codeine)    -   Hydrocodone and Ibuprofen (Hydrostal IR, Vicoprofen)    -   Pentazocine/Naloxone (Talwin NX)    -   Acetaminophen and Codeine (Capital with Codeine, Margesic #3,        Phenaphen with Codeine, Tylenol with Codeine)    -   Dihydrocodeine, Acetaminophen, and Caffeine (DHCplus)    -   Hydrocodone and Acetaminophen (Allay, Anexsia 5/500, Anexsia        7.5/650, Dolacet, Dolagesic, Duocet, Hycomed, Hydrocet,        Hydrogesic, HY—PHEN, Lorcet 10/650, Lorcet-HD, Lortab, Panacet        5/500, Panlor, Stagesic, T-Gesic, Ugesic, Vicodin, Zydone)    -   Oxycodone and Acetaminophen (Endocet, Percocet, Roxicet,        Roxilox, Tylox)    -   Pentazocine and Acetaminophen (Talacen)    -   Propoxyphene and Acetaminophen (Darvocet-N 50, Darvocet-N 100,        E-Lor, Propacet 100)    -   Aspirin, Caffein and Dihydrocodeine (Synalgos-DC)    -   Aspirin and Codeine (Empirin with Codeine)    -   Hydrocodone and Aspirin (Damason-P, Lortab ASA, Panasal 5/500)    -   Oxycodone and Aspirin (Endodan, Percodan, Percodan-Demi,        Roxiprin)    -   Pentazocine and Aspirin (Talwin Compound)    -   Propoxyphene, Aspirin, and Caffeine (Darvon Compound 65, PC-Cap,        Propoxyphene Compound 65)    -   Capsaicin (ArthriCare, ARTH-RX, Axsain, Capsagel, Dura-Patch,        Methacin, Zotrix, Zotrix-HP)    -   Benzocaine (Americaine, Endocaine, Lagol)    -   Benzocaine/Menthol (Benzocol, Butyl Aminobenzoate, Dermoplast)    -   Dibucaine (Cinchocaine, Nupercainal Cream, Nupercainal Ointment)    -   Lidocaine (LidaMantle, Lidoderm, Lignocainem, Xylocalne)    -   Lidocaine/Prilocalne (EMLA)

Topical Neurotoxins

-   -   onabotulinumtoxinA (Botox)    -   abobotulinumtoxinA (Dysport)    -   incobotulinumtoxinA (Xeomin)    -   Botulinum Toxin Type A (Purtox)

Topical Insect Repellents

-   -   DEET (N,N-diethyl-m-toluamide)    -   Essential Oil (Corymbia citriodora/p-menthane-3,8-diol [PMD])    -   Icaridin (Picaridin, Bayrepel, KBR 3023)    -   Nepetalactone (Catnip Oil)    -   Citronella oil    -   Permethrin    -   Neem oil    -   Bog Myrtle    -   IR 3535 (3-[N-Butyl-N-acetyl]-aminopropionic acid, ethyl ester)

Sunscreen Active Ingredients

-   -   p-Aminobenzoic acid (PABA)    -   Padimate O (OD-PABA, octyldimethyl-PABA or σ-PABA)    -   Phenylbenzimidazole sulfonic acid (Ensulizole, Eusolex 232, PBSA        or Parsol HS)    -   Cinoxate (2-Ethoxyethyl p-methoxycinnamate)    -   Dioxybenzone (Benzophenone-8)    -   Oxybenzone (Benzophenone-3, Eusolex 4360 or Escalol 567)    -   Homosalate (Homomethyl salicylate or HMS)    -   Menthyl anthranilate (Meradimate)    -   Octocrylene (Eusolex OCR, 2-cyano-3,3diphenyl acrylic acid, or        2-ethylhexylester)    -   Octyl methoxycinnamate (Octinoxate, EMC, OMC,        Ethylmethoxycinnamate, Escalol 557,        2-ethylhexyl-paramethoxycinnamate or Parsol MCX)    -   Octyl salicylate (Octisalate, 2-Ethylhexyl salicylate or Escalol        587)    -   Sulisobenzone (2-Hydroxy-4-Methoxybenzophenone-5-sulfonic acid,        3-benzoyl-4-hydroxy-6-methoxybenzenesulfonic acid,        Benzophenone-4 or Escalol 577)    -   Trolamine salicylate (Triethanolamine salicylate)    -   Avobenzone        (1-(4-methoxyphenyl)-3-(4-tert-butylphenyl)propane-1,3-dione,        Butyl methoxy dibenzoylmethane, BMDBM, Parsol 1789 or Eusolex        9020)    -   Ecamsule (Mexoryl SX or Terephthalylidene Dicamphor Sulfonic        Acid)    -   Titanium dioxide (CI77891)    -   Zinc oxide    -   4-Methylbenzylidene camphor (Enzacamene, Parsol 5000, Eusolex        6300 or MBC)    -   Tinosorb M (Bisoctrizole, Methylene Bis-Benzotriazolyl,        Tetramethylbutylphenol or MBBT)    -   Tinosorb S (Bis-ethylhexyloxyphenol methoxyphenol triazine,        Bemotrizinol, BEMT or anisotriazine)    -   Neo Heliopan AP (Bisdisulizole Disodium, Disodium phenyl        dibenzimidazole tetrasulfonate, bisimidazylate or DPDT)    -   Mexoryl XL (Drometrizole Trisiloxane)    -   Benzophenone-9 (Uvinul DS 49, CAS 3121-60-6 or Sodium Dihydroxy        Dimethoxy Disulfobenzophenone)    -   Uvinul T 150 (Octyl triazone, ethylhexyl triazone or EHT)    -   Uvinul A Plus (Diethylamino Hydroxybenzoyl Hexyl Benzoate)    -   Uvasorb HEB (Iscotrizinol, Diethylhexyl butamido triazone or        DBT)    -   Parsol SLX (Dimethico-diethylbenzalmalonate, Polysilicone-15)    -   Isopentenyl-4-methoxycinnamate (Isoamyl p-Methoxycinnamate, IMC,        Neo Heliopan E1000, Amiloxate)

FANCOL VB

FANCOL VB (also known as FANCOL or Butyrospermum Parkii ButterLimnanthes Alba Seed Oil) is employed as a base ingredient in the basecompositions of the invention, and in the topical activeagent-containing compositions of the invention, and functions primarilyto cause, or aid in causing (generally in combination with one or moreother ingredients), such compositions to properly form, or be present ina form of, a solid or semi-solid structure (preferably a solid stick),but may also function to moisturize, condition and/or protect theepidermal and/or other layers of the skin, to promote skin pigmentwetting, skin penetration of active agents, spreadability on the skin,skin shine and/or binding of various composition ingredients together.

FANCOL VB consists of vegetable derived lipids and sterol enriched sheabutter extract. Its INCI name is Limnanthes Alba (Meadowfoam) Seed Oil,Butyrospermum Parkii (Shea Butter) Extract, and it preferably has thechemical and physical data shown below.

Chemical and Physical Data

-   -   Color (Gardner) 3 max.    -   Saponification Value 175 max.    -   Iodine Value 105 max.    -   Acid Value 0.5 max.        The solubility of FANCOL VB in various other ingredients or        compositions at both 25° C. and 75° C. is shown below.

Solubility of FANCOL VB at 25° C. and 75° C.

Composition 25° C. 75° C. Castor Oil Soluble Soluble (Clear Solution)(Clear Solution) Mineral Oil Soluble Soluble (Clear Solution) (ClearSolution) Propylene Insoluble Insoluble Glycol Glycerine InsolubleInsoluble Ethyl Soluble Soluble Acetate (Clear Solution) (ClearSolution) Ethyl Insoluble Soluble Alcohol (Clear Solution) WaterInsoluble Slightly Soluble Isopropyl Soluble Soluble Myristate (ClearSolution) (Clear Solution)

FANCOL VB is commercially available from sources that are known by thosehaving ordinary skill in the art, for example, from The FanningCorporation (Chicago, Ill.) or Elementis Specialties, Inc. (Hightstown,N.J.).

The amount of FANCOL VB that is present in the active agent-containingcompositions of the invention is an amount that is effective to causethe compositions to have one or more of the beneficial characteristicsthat are described herein, such as causing, or aiding in causing(generally in combination with one or more other ingredients), suchcompositions to properly form, or be present in a form of, a solidstructure, or semi-solid structure, or example, in the shape of a solidstick (i.e., cylinder shaped), or any another shape desired or required,or present in a pot or jar.

Original Active Agent-Containing Compositions

When none of the above-described optional base ingredients is present inthe original active agent-containing compositions of the invention, theamount of FANCOL VB that is present in these compositions preferablyranges from about 13 to about 25 weight percent, and more preferablyranges from about 16 to about 22 weight percent (with the totalcompositions having 100 percent weight). When, however, one or more ofsuch optional base ingredients is present in these compositions, theamount of FANCOL VB that is present therein may be much less, such asabout 9 weight percent (or possibly even lower, depending upon thenumber of optional base ingredients included in these compositions, andthe weight percents thereof), and preferably ranges from about 9 toabout 13 weight percent, and more preferably ranges from about 10 toabout 12 weight percent.

Improved Active Agent-Containing Compositions

The amount of FANCOL VB that is present in the improved activeagent-containing compositions of the invention preferably ranges fromabout 6 to about 25 weight percent, and more preferably ranges fromabout 6 to about 16 weight percent, and still more preferably rangesfrom about 10 to about 12 weight percent, and is most preferably about11 weight percent (whether or not any favoring ingredients are presentin the compositions).

Additional information about FANCOL VB is present at the ElementisSpecialties, Inc. Internet web site and at other web sites known bythose having ordinary skill in the art.

Natunola Castor 1023

Natunola Castor 1023 (INCI name Ricinus Communis (Castor) Seed Oil (and)Glycine Soja (Soybean) Germ Extract (and) Zea Mays (Corn) Starch (and)Silica,) is employed as a base ingredient in the compositions of theinvention, and in the topical active agent-containing compositions ofthe invention. It functions primarily to cause, or aid in causing(generally in combination with one or more other ingredients), suchcompositions to properly form, or be present in a form of, a solid orsemi-solid structure (preferably a solid stick), but may also functionto soften the skin and to bind various composition ingredients together,and typically resists oxidation, and has a high degree of stability.

Natunola Castor 1023 is a glossy gel that is derived from castor oil(ricinus communis) which, in turn, is derived from the bean of theCastor plant Ricinus communis, and is the primary component withinNatunola Castor 1023, with the other components being glycerine soybeangerm extract, corn starch and silica. It typically has the followingcharacteristics:

Characteristics

-   -   Appearance: clear, transparent gel    -   Odor: light, characteristic    -   Solubility: soluble in all vegetable oils, glycerol        tri-isostearate, isostearyl isostearate, oleic acid, isostearic        acid, coco-caprylate/caprate and mixed glycerides; insoluble in        water silicone oil; partially soluble in ethanol and        1,2propanediol    -   pH (1:20 water emulsion): 4.6-6.6    -   Stability: Stable at room temperature    -   Formulating pH: a pH range of from about 3 to about 8 is        preferred    -   Formulating Temperature: a working temperature range of from        about 45° C. to about 95° C. is preferred

Natunola Castor 1023 is commercially available from sources that areknown by those having ordinary skill in the art, for example, fromNatunola Health Biosciences, Inc. (Winchester, Ontario, Canada) orNatunola Health, Inc. (Winchester, Ontario, Canada), or distributors orretailers thereof, which are known by those having ordinary skill in theart.

The amount of Natunola Castor 1023 that is present in the activeagent-containing compositions of the invention is an amount that iseffective to cause the compositions to have one or more of thebeneficial characteristics that are described herein, such as causing,or aiding in causing (generally in combination with one or more otheringredients), such compositions to properly form, or be present in aform of, a solid or semi-solid structure, for example, in the shape of astick, or in any another shape desired or required, or present in a potor jar.

Original Active-Agent Containing Compositions

When none of the above-described optional base ingredients is present inthe original active agent-containing compositions of the invention, theamount of Natunola Castor 1023 that is present in these compositionspreferably ranges from about 23 to about 39 weight percent, and morepreferably ranges from about 26 to about 35 weight percent (with thetotal compositions having 100 percent weight). When, however, one ormore of such optional base ingredients is present in these compositions,the amount of Natunola Castor 1023 that is present therein may be muchless, such as about 16 weight percent (or possibly even lower, dependingupon the number of optional base ingredients included in thesecompositions, and the weight percents thereof), and preferably rangesfrom about 16 to about 20 weight percent, and more preferably rangesfrom about 17 to about 19 weight percent.

Improved Active Agent-Containing Compositions

The amount of Natunola Castor 1023 that is present in the improvedactive agent-containing compositions of the invention preferably rangesfrom about 5 to about 39 weight percent, and more preferably ranges fromabout 5 to about 15 weight percent, and still more preferably rangesfrom about 9 to about 11 weight percent, and is most preferably about 10weight percent (whether or not any favoring ingredients are present inthe compositions).

Additional information about Natunola Castor 1023 is present at aNatunola Health Biosciences, Inc. or Natunola Health, Inc. Internet website and at other web sites known by those having ordinary skill in theart.

Finsolv TN

Finsolv TN (INCI name C₁₂₋₁₅ Alkyl Benzoate, CAS Registry Number68411-27-8, EINECS Number 270-1,2-4, also known as Finsolv) is employedas a base ingredient in the compositions of the invention, and in thetopical active agent-containing compositions of the invention, andfunctions primarily as an emollient, but may also function to as abinder (to bind composition ingredients together), a thickening agent, adispersing aid and/or a lubricant therein. C₁₂₋₁₅ Alkyl Benzoate is theester of benzoic acid and C₁₂₋₁₅ alcohols (q.v.), and conforms to aformula below in which R represents a C₁₂₋₁₅ alkyl group (C₁₂, C₁₃, C₁₄and/or C₁₅):

Finsolv TN is an emollient ester that typically is non-toxic,non-irritating, non-sensitizing, water insoluble, readily emulsifiableand stable over a wide pH range, and has a high positive spreadingcoefficient. It typically has the following properties:

Properties

-   -   Appearance: clear, almost colorless liquid    -   Odor: very mild, and practically odorless    -   Boiling Point: 300° C. (572° F.)    -   Pour Point: 14° C. (approximately)    -   Freezing Point Range: −3 to −12° C.    -   Flash Point: 163-166° C.    -   Specific Gravity at 25° C.: 0.928    -   Refractive Index at 20° C.: 1.485    -   Surface Tension at 15° C.: 31.5 dynes/cm    -   Interfacial Tension in Water at 15° C.: 7.13 dynes/cm    -   Spreading Coefficient at 15° C.: 34.5 dynes/cm    -   Viscosity (Brookfield at 70° F., RV #1 Spindle, 100 RPM): 38 cps    -   Acidity (mg KOH/g): <0.10%    -   % Moisture: <0.10

Finsolv TN is commercially available from sources that are known bythose having ordinary skill in the art, for example, from Finetex, Inc.(Elmwood Park, N.J.) or Innospec Active Chemicals, LLC (Edison, N.J.).

The amount of Finsolv TN that is present in the active agent-containingcompositions of the invention is an amount that is effective to causethe compositions to have one or more of the beneficial characteristicsthat are described herein, such as causing, or aiding in causing(possibly along with one or more other ingredients), such compositionsto function as an emollient upon the skin (i.e., to render the skin moresoft than it would have been prior to applying the compositionsthereto).

Original Active-Agent Containing Compositions

When none of the above-described optional base ingredients is present inthe original active agent-containing compositions of the invention, theamount of Finsolv TN that is present in these compositions preferablyranges from about 13 to about 25 weight percent, and more preferablyranges from about 16 to about 22 weight percent (with the totalcompositions having 100 percent weight). When, however, one or more ofsuch optional base ingredients is present in these compositions, theamount of Finsolv TN that is present therein may be much less, such asabout 9 weight percent (or possibly even lower, depending upon thenumber of optional base ingredients included in these compositions, andthe weight percents thereof), and preferably ranges from about 9 toabout 13 weight percent, and more preferably ranges from about 10 toabout 12 weight percent.

Improved Active Agent-Containing Compositions

The amount of Finsolv TN that is present in the improved activeagent-containing compositions of the invention preferably ranges fromabout 9 to about 25 weight percent, and more preferably ranges fromabout 10 to about 20 weight percent, and still more preferably rangesfrom about 14 to about 16 weight percent, and is most preferably about15 weight percent (whether or not any favoring ingredients are presentin the compositions).

Additional information about Finsolv TN is present at an Innospec ActiveChemicals, LLC Internet web site and at other web sites known by thosehaving ordinary skill in the art.

Bees Wax

Bees wax (also known as Cera alba and Cera flava) is employed as a baseingredient in the compositions of the invention, and in the topicalactive agent-containing compositions of the invention, and it functionsprimarily to cause, or aid in causing (generally in combination with oneor more other ingredients), such compositions to properly form, or bepresent in a form of, a solid structure (preferably a solid stick), butmay also function as a moisturizing agent, a softening agent, athickening agent, an emollient (skin softener) and/or a provider of skinprotective action (of the nonoclusive type). It typically protects theskin from, for example, damaging environmental factors, such aschemicals, adverse weather conditions, and the like, by providing skinwith a protective coating against environmental elements. Bees waxpermits, or helps permit, the compositions of the invention to beformulated into a desired form and shape, such as a stick that is soft,somewhat rigid or relatively hard (generally firm and/or very rigid),such as a traditional ChapStick® form. It also functions as a binder(helping to bind all of the composition ingredients together).

Bees wax is generally a colorless, nutrient-rich, liquid lipid that issecreted from special abdominal glands of honey bee, Apis Mellifera,generally as they build honeycomb walls, and transforms into asemi-solid substance upon contact with the atmosphere. It typically isnon-allergenic and has water repellent properties, and may be purifiedfrom its raw state by freeing it of solid impurities by melting andcentrifugation. Bees wax typically contains from about 10 to about 15percent paraffin carbohydrates, from about 35 to about 37 percent estersof C₁₆ to C₃₆ fatty acids and about 15 percent cerotic acid, melis sicacid and their homologues. Typically, bees wax has a melting point offrom about 62° C. to about 65° C., has an acid value of from about 17 toabout 24, has a saponification value of from about 89 to about 103, andhas an ester value of from about 72 to about 79.

Bees wax is commercially available from sources that are known by thosehaving ordinary skill in the art, for example, from Columbus FoodsCompany (Des Plaines, Ill.) or Hangzhou Golden Harvest Health IndustryCo., Ltd. (Zhejiang, China).

The amount of bees wax that is present in the active agent-containingcompositions of the invention is an amount that is effective to causethe compositions to have one or more of the beneficial characteristicsthat are described herein, such as causing, or aiding in causing(generally in combination with one or more other ingredients), suchcompositions to properly form, or be present in a form of, a solid orsemi-solid structure, for example, in the shape of a stick or anyanother shape desired or required, or present in a pot or jar.

Original Active-Agent Containing Compositions

When none of the above-described optional base ingredients is present inthe original active agent-containing compositions of the invention, theamount of bees wax that is present in these compositions preferablyranges from about 26 to about 43 weight percent, and more preferablyranges from about 29 to about 39 weight percent (with the totalcompositions having 100 percent weight). When, however, one or more ofsuch optional base ingredients is present in these compositions, theamount of bees wax that is present therein may be much less, such asabout 18 weight percent (or possibly even lower, depending upon thenumber of optional base ingredients included in these compositions, andthe weight percents thereof), and preferably ranges from about 18 toabout 22 weight percent, and more preferably ranges from about 19 toabout 21 weight percent.

Improved Active Agent-Containing Compositions

The amount of bees wax that is present in the improved activeagent-containing compositions of the invention preferably ranges fromabout 6 to about 43 weight percent, and more preferably ranges fromabout 6 to about 16 weight percent, and still more preferably rangesfrom about 10 to about 12 weight percent, and is most preferably about11 weight percent (whether or not any favoring ingredients are presentin the compositions).

Additional information about bees wax is present in, for example, RogerA. Morse et al., “Beeswax: Production, Harvesting, Processing andProducts” (Wicwas Pr, 1st Edition, ISBN-10: 1878075063, 1984); and HuberH. Root, “Beeswax: Its Properties, Testing, Production and Applications”(Chemical Pub. Co., ASIN: B0007E742G, 1951).

Plant and Plant Seed Oils

One or a plurality of plant or plant seed oils (i.e., oils procured orderived from one or more parts of a plant, shrub or tree, such as aroot, stem, bark, leaf, flower, seed, fruit and/or the like) (or othersimilar oils) are optionally, but preferably, employed as a baseingredient in the base compositions of the invention, and in the topicalactive agent-containing compositions of the invention, and functionsprimarily as an emollient (skin softener), but may also function as alubricant and/or binder. Preferred plant or plant seed oils for use inthe base and active agent-containing compositions of the inventioninclude Castor Oil, Rice Brand Oil, Coconut Oil, Sunflower Oil and OliveOil, with Castor Oil being the most preferred such oil, and ispreferably present therein (without other plant or plant seed oils). Awide variety of plant and plant seed oils are known by those havingordinary skill in the art and/or are described elsewhere herein andbelow.

Plant and plant seed oils (or possibly fats in some cases) that may beemployed in the base and other compositions of the invention include,but are not limited to, Soybean Oil, Rapeseed Oil, Cottonseed Oil,Sunflower Seed Oil, Ground Nut Oil, Palm Oil, Palm Kernel Oil, PeanutOil, Copra Oil, Sesame Oil, Sesame Seed Oil, Linseed Oil, Castor Oil,Maize Oil, Coconut Oil, Olive Oil, Almond Oil, Coffee Oil, Costus RootOil, Agarwood (Aquilaria Malaccensis)(Agar) Oil, Angelica Archangelica(Angelica Root) Oil, Apricot Kernel Oil, Artemisia Dracunculus(Tarragon) Oil, Artemisia Pallens (Davana) Oil, Asafoetida Oil, AvocadoOil, Babassu Oil, Basil Oil, Bay Oil, Bergamot Oil, Birch Oil, BorageOil, Buchu Shrub (Buchu) Oil, Calamus Root Oil, Calendula Oil, CamelliaOil, Camphor Oil, Cannabis Flower Essential Oil, Canola Oil, CarawayOil, Carrot Seed Oil (Essential Oil), Carum Copticum (Ajwain) Oil,Cedarwood Oil, Cetyl Rinoleate, Chamomile Oil, Cinnamon Oil, CistusSpecies Oil, Citronella Oil, Clary Sage Oil, Clove Leaf Oil, CoconutOil, Cocos Nucifera (Coconut) Oil, Coriander Oil, Corn Oil, Costus RootOil, Cranberry Seed Oil, Cumin Oil, Black Seed Oil, Curry Leaf Oil,Cypress Oil, Cypriol Oil, Dill Oil, Elecampane Oil, Elettaria Cardamomum(Cardamom) Seed Oil, Emu Oil, Ethyl Ricinoleate Oil, Eucalyptus Globulus(Eucalyptus) Leaf Oil, Eugenia Caryophyllus (Clove) Flower Oil, EveningPrimrose Oil, Fennel Seed Oil, Fenugreek Oil, Fir Oil, Flax (Linseed)Oil, Florentine Iris (Iris Florentina) (Orris) Oil, Frankincense Oil,Galangal Oil, Galbanum Oil, Geranium Oil, Ginger Oil, GlycerylRicinoleate, Glyceryl Ricinoleate Se, Glycol Ricinoleate, Goldenrod Oil,Grapefruit Oil, Grapeseed Oil, Hazelnut Oil, Helichrysum Oil, Hemp SeedOil, Henna Oil, Horseradish Oil, Hydrogenated Castor Oil, Hyssop Oil,Idaho Tansy Oil, Illicium Verum (Anise) Oil, Illipe Oil, IsopropylRicinoleate, Jasmine Oil, Jojoba Oil, Juniper Berry Oil, Kukui Nut Oil,Laurus Nobilis Oil, Lavender Oil, Ledum Oil, Lemongrass Oil, Lime Oil,Litsea Cubeba Oil, Macadamia Nut Oil, Marjoram Oil, Meadowfoam Oil,Melaleuca Alternifolia (Tea Tree) Oil, Melissa Oil (Lemon Balm), MenthaArvensis (Mint) Oil, Mentha Viridis (Spearmint) Leaf Oil, MethylRicinoleate, Mink Oil, Monoi De Tahiti, Mountain Savory Oil, MugwortOil, Mustard Oil (Essential Oil), Myroxylon Pereirae (Balsam) Oil, MyrrhOil, Myrtle Oil, Neem Oil, Neem Tree Oil, Neroli, Nutmeg Oil,Octyldodecyl Ricinoleate, Olive Oil, Orange Oil, Oregano Oil, PalmKernel Oil, Palm Oil, Palo Santo Oil, Parsley Oil, Patchouli Oil,Pennyroyal Oil, Peppermint Oil, Perilla Essential Oil, Petitgrain Oil,Pimpinella Anisum (Anise) Oil, Pine Oil, Piper Nigrum (Black Pepper)Essential Oil, Plum Kernel Oil, Pomegranate Oil, Potassium Ricinoleate,Prunus Dulcis (Almond) Oil, Pumpkin Seed Oil, Ravensara Oil, Red CedarOil, Red Palm Oil, Rice Bran Oil, Ricinoleic Acid, Roman Chamomile Oil,Rosa Mosqueta (Rosehip) Oil, Rosa Rubiginosa (Rosehip) Oil, Rose Oil,Rosehip Seed Oil, Rosewood Oil, Rosmarinus Officinalis (Rosemary) Oil,Safflower Oil, Sage Oil, Sandalwood Oil, Sassafras Root Bark (Sassafras)Oil, Satureja Species (Savory) Oil, Schisandra Chinensis (Schisandra)Oil, Sesame Oil, Shea Nut Oil, Sodium Ricinoleate Oil, Spearmint Oil,Spice Star Anise (Star Anise) Oil, Spikenard Oil, Spruce Oil, SunflowerOil, Sweet Almond Oil, Tamanu Oil, Tanacetum Balsamita (Costmary) Oil,Tangerine Oil, Thyme Oil, Tsuga Oil, Turmeric Oil, Valerian Oil, VetiverOil (Khus Oil), Vitis Vinifera (Grape) Seed Oil, Walnut Oil, Western RedCedar Oil, Wheat Germ Oil, Wintergreen Oil, Yarrow Oil, Ylang-Ylang Oil,Zedoary Oil, Zinc Ricinoleate Oil, Zingiberaceae (Ginger) (CardamomSeed) Oil, and/or the like.

Castor Oil, which is the most preferred plant or plant seed oil for usein the base compositions and active agent-containing compositions of theinvention, is derived from the seeds of the Castor Oil plant, andtypically consists of from about 87% to about 90% ricinoleic acid (majorcomponent), about 7% oleic acid, about 3% linoleic acid, about 2%palmitic acid and about 1% stearic acid. Most chemical and physicalproperties of Castor Oil are based on the molecular structure ofricinoleic acid.

Ricinoleic Acid

Castor oil, and other plant and plant seed (and other) oils, arecommercially available from sources that are known by those havingordinary skill in the art, for example, from Rita Corporation (CrystalLake, Ill.), Bulkoil.com (Greenbrae, Calif.) and Inner Mongolia TianrunCastor Development Co., Ltd. (Inner Mongolia, China).

The amount (combined) of one or more plant or plant seed oils that isoptionally present in the active agent-containing compositions of theinvention, such as Castor oil, is an amount that is effective to causethe compositions to have one or more of the beneficial characteristicsthat are described herein, such as causing, or aiding in causing(possibly along with one or more other ingredients), such compositionsto function as an emollient upon the skin (i.e., to render the skin moresoft than it would have been prior to applying the compositionsthereto).

Original Active Agent-Containing Compositions

When present in the original active agent-containing compositions, theamount (combined) of one or more plant or plant seed oils that ispresent therein preferably ranges from about 0.1 to about 24 weightpercent, and more preferably ranges from about 8 to about 17 weightpercent, and still more preferably ranges from about 10 to about 15weight percent, and even more preferably ranges from about 11 to about12 weight percent.

Improved Active Agent-Containing Compositions

When present in the improved active agent-containing compositions, theplant oil(s) and/or plant seed oil(s), such as castor oil, preferably ispresent in the compositions in an amount (combined) preferably rangingfrom about 0.1 to about 37.50 (from about 0.1 to about 37.0 if one ormore flavoring ingredients are present) weight percent, and morepreferably ranging from about 12.50 to about 37.50 (from about 12.0 toabout 37.0 if one or more flavoring ingredients are present) weightpercent, and still more preferably ranging from about 24.0 to about 26.0(from about 23.50 to about 25.50 if one or more flavoring ingredientsare present), and is most preferably about 25.0 (about 24.5 if one ormore flavoring ingredients are present) weight percent.

Additional information about plant and plant seed oils generally, andabout Caster Oil specifically, including extraction and refining methodstherefore, is present in, for example, Carol Schiller et al., “TheAromatherapy Encyclopedia: A Concise Guide to over 385 Plant Oils”(Basic Health Publications, 1st Edition, ISBN-10: 1591202280, 2008);Frederic P. Miller, “Castor Oil” (Alphascript Publishing, ISBN-10:6130261918, 2009); D. S. Oqunniyi, “Castor Oil: A Vital Industrial RawMaterial (Bioresource Technology)” (Elsevier, 2006); Johann Vollmann,“Oil Crops: Handbook of Plant Breeding” (Springer, 1st Edition, ISBN-10:0387775935, 2009); Hermann Janson, “Castor Oil Production andProcessing” (United Nations, ASIN: B0006DZ23G, 1974); and/or ErnestGuenther, “The Essential Oils, Individual Essential Oils of the PlantFamilies” (Krieger Pub Co., ISBN-10: 0894647733, 1992).

Fatty Alcohols

One or a plurality of fatty alcohols, such as stearyl alcohol, isoptionally, but preferably, employed as a base ingredient in thecompositions of the invention, and in the topical activeagent-containing compositions of the invention, and functions primarilyto cause, or aid in causing (generally in combination with one or moreother ingredients), such compositions to properly form, or be present ina form of, a solid or semi-solid structure (preferably a solid stick),but may also function as an emollient (skin softener), thickener and/orbinding agent therein. The fatty alcohol often functions as a bondingagent that binds, or helps bind, all of the ingredients in thecompositions together.

Preferred fatty alcohols for use in the base and active agent-containingcompositions of the invention include stearyl alcohol, cetyl alcohol,cetyl stearyl alcohol and behenyl alcohol, with stearyl alcohol beingthe most preferred, and is preferably present therein (without otherfatty alcohols). A wide variety of other fatty alcohols are known bythose having ordinary skill in the art and are described in sources thatare known by those having ordinary skill in the art, such as in StephenMudge, “Fatty Alcohols: Anthropogenic and Natural Occurrence in theEnvironment” (Royal Society of Chemistry, 1st Edition, ISBN-10:0854041524, 2008).

Stearyl alcohol (also known as octadecyl alcohol or 1-octadecanol),which is the most preferred fatty alcohol for use in the basecompositions and active agent-containing compositions of the invention,is a substance prepared from stearic acid by the process of catalytichydrogenation, and has the molecular formula C₁₈H₃₈₀. It is a fattyalcohol that generally is in the form of white solid granules or flakesthat are insoluble in water, and has a melting point of 60° C. and aboiling point of 210° C. (at 15 mmHg or 2.0 kPa).

Stearyl Alcohol

Stearyl alcohol, and other fatty alcohols, are commercially availablefrom sources that are known by those having ordinary skill in the art,for example, from Rita Corporation (Woodstock, Ill.), Sciencelab.com,Inc. (Houston, Tex.) or Alpha Aesar (Ward Hill, Mass.).

Examples of other fatty alcohols that may be employed in the basecompositions and active agent-containing compositions of the inventioninclude, but are not limited, to Stearamine Oxide, Stearyl Acetate,Stearyl Caprylate, Stearyl Citrate, Stearyldimethyl Amine, StearylGlycyrrhetinate, Stearyl Heptanoate, Stearyl Octanoate, StearylStearate, Plant Sources, Vegetable Stearic Acid, Cetyl Alcohol,Arachidyl Alcohol, Behenyl Alcohol, Capric Alcohol, Capryl Alcohol,Ceryl Alcohol, Cetearyl Alcohol, Cetyl Alcohol, Cluytyl Alcohol,Elaidolinolenyl Alcohol, Elaidolinoleyl Alcohol, Elaidyl Alcohol, ErucylAlcohol, Geddyl Alcohol, Heneicosyl, Heptadecyl Alcohol, IsostearylAlcohol, Lauryl Alcohol, Lignoceryl Alcohol, Linolenyl Alcohol, LinoleylAlcohol, Melissyl Alcohol, Montanyl Alcohol, Myricyl Alcohol, MyristylAlcohol, Nonadecyl Alcohol, Oleyl Alcohol, Palmitoleyl Alcohol,Pelargonic Alcohol, Pentadecyl Alcohol, Ricinoleyl Alcohol, TridecylAlcohol, Undecyl Alcohol and Isostearyl Alcohol.

The amount (combined) of one or more fatty alcohols that is optionallypresent in the active agent-containing compositions of the invention isan amount that is effective to cause the compositions to have one ormore of the beneficial characteristics that are described herein, suchas causing, or aiding in causing (generally in combination with one ormore other ingredients), such compositions to properly form, or bepresent in a form of, a solid or semi-solid structure, for example, inthe shape of a stick or any another shape desired or required, orpresent in a pot or jar.

Original Active Agent-Containing Compositions

When present in the original active agent-containing compositions, theamount (combined) of one or more fatty alcohols that is present in thesecompositions, such as stearyl alcohol, preferably ranges from about 0.1to about 22 weight percent, and more preferably ranges from about 10 toabout 22 weight percent, and still more preferably ranges from about 18to about 22 weight percent.

Improved Active Agent-Containing Compositions

When present in the improved active agent-containing compositions, thefatty alcohol(s), such as stearyl alcohol, preferably is present in thecompositions in an amount (combined) preferably ranging from about 0.1to about 25 weight percent, and more preferably ranging from about 15 toabout 25 weight percent, and still more preferably ranging from about 19to about 21 weight percent, and is most preferably about 20 weightpercent (whether or not any favoring ingredients are present in thecompositions).

Additional information about fatty alcohols is present, for example, inSylvia S. Talmage, “Environmental and Human Safety of Major Surfactants:Alcohol Ethoxylates and Alkylphenol Ethoxylates” (CRC Press, 1stEdition, ISBN-10: 1566700175, 1994); and Egon Matijevic, “Surface andColloid Science, Vol. 16” (Springer, 1st Edition, ISBN-10: 030646456X,2001).

Fats

One or a plurality of fats, preferably having a melting point of atleast about 85° F. (29.444° C.), such as from about 34° C. to about 38°C. (from about 93° F. to about 100° F.), and which more preferably havea melting point of at least about 90° F. (32.222° C.) or higher, such ascocoa butter (also called theobroma oil or theobroma cacao), isoptionally, but preferably, employed as a base ingredient in thecompositions of the invention, and in the topical activeagent-containing compositions of the invention. Such fat(s) functionprimarily to cause, or aid in causing (generally in combination with oneor more other ingredients), such compositions to properly form, or bepresent in a form of, a solid structure (preferably a solid stick), butmay also function as an emollient (skin softener), a moisturizer and/ora binding agent therein.

Examples of fats (and possibly oils in some cases) that may be employedin base and other compositions of the invention include, but are notlimited, to Cocoa Butter, Shea Butter, Shea Nut Butter, Mango Butter,Costus Root, Calamas Root, Canola, Crisco, Cubeb, Ethyl Ricinoleate,Kokum Butter, Lanolin, Lard, Mowrah Butter and Tallow (Beef). A widevariety of fats are known by those having ordinary skill in the art andare described in sources that are known by those having ordinary skillin the art, such as in Richard D. Obrien, “Fats and Oils: Formulatingand Processing for Applications” (CRC Press, 3rd Edition, ISBN-10:1420061666, 2008), Glen D. Lawrence, “The Fats of Life: Essential FattyAcids in Health and Disease” (Rutgers University Press, ISBN-10:081354677X, 2010), and Icon Group International, “The 2009 Report onConfectionery and Ice Cream Coatings made from Cacao Bean Cocoa and Fatsother than Cocoa Butter: World Market Segmentation by City” (ICON GroupInternational, Inc., ASIN: B002AJG6AC, 2009).

Preferred fats for use in the base compositions and activeagent-containing compositions of the invention include cocoa butter,shea butter and mango butter, with cocoa butter being the mostpreferred, and preferably present therein alone (i.e. without otherfats).

Typically, cocoa butter is solid at room temperature, but readily meltsat body temperature. It generally has a melting point of from about 34°C. to about 38° C. (from about 93° F. to about 100° F.). Cocoa butterdisplays polymorphism, generally having α, γ, β′ and β crystals, withmelting points of about 17, 23, 26 and 35-37° C., respectively, with theβ crystal form being the most stable form.

Cocoa butter, and other fats, are commercially available from sourcesthat are known by those having ordinary skill in the art, for example,from Rita Corporation (Crystal Lake, Ill.) and Bulkoil.com (Greenbrae,Calif.).

The amount (combined) of one or fats that is optionally present in theactive agent-containing compositions of the invention, such as cocoabutter, is an amount that is effective to cause the compositions to haveone or more of the beneficial characteristics that are described herein,such as causing, or aiding in causing (generally in combination with oneor more other ingredients), such compositions to properly form, or bepresent in a form of, a solid or semi-solid structure, for example, inthe shape of a stick or any another shape desired or required, orpresent in a pot or jar.

Original Active Agent-Containing Compositions

When present in the original active agent-containing compositions, theamount (combined) of the one or more fats that is present thereinpreferably ranges from about 0.1 to about 9 weight percent, and morepreferably ranges from about 5 to about 9 weight percent, and still morepreferably ranges from about 6 to about 8 weight percent.

Improved Active Agent-Containing Compositions

When present in the improved active agent-containing compositions, thefat(s), such as cocoa butter, preferably is present in the compositionsin an amount (combined) preferably ranging from about 0.1 to about 12weight percent, and more preferably ranging from about 2 to about 12weight percent, and still more preferably ranging from about 6 to about8 weight percent, and is most preferably about 7 weight percent (whetheror not any favoring ingredients are present in the base compositions).

Additional information about fats is present, for example, in RobinDand, “The International Cocoa Trade” (CRC Press, 2nd edition, ISBN-10:0849322669, 1999); and Emmanuel Ohene Afoakwa, “Chocolate Science andTechnology” (Wiley-Blackwell, ISBN-10: 1405199067, 2010).

Flavorings

One or more flavorings are, optionally, but preferably, employed as abase ingredient in the compositions of the invention, and in the topicalactive agent-containing compositions of the invention, and function to:(i) provide such compositions with a desirable and/or distinct aroma,fragrance and/or taste (i.e., they make the compositions smell and/ortaste good and/or otherwise desirable to consumers thereof, who mayapply them to their lips); and/or (ii) effectively reduce, mask oreliminate one or more bitter and/or other undesirable tastes and/orodors that are caused by, or otherwise result from, an inclusion of adifferent ingredient in these compositions, such as hydrocortisone,which has a very bitter taste and odor, and generally causescompositions including hydrocortisone to have a very undesirable bittertaste and odor.

The flavorings that may be employed in the active agent-containingcompositions of the invention may vary widely and include, but are notlimited to, vanilla, chocolate, citrus flavors (lemon, orange,grapefruit and/or the like), fruit flavors (strawberry, cherry, kiwi,pineapple, blueberry, apple, grape, pear, cantaloupe and/or the like),cinnamon, mint (spearmint, peppermint, wintergreen and/or the like),pina colada, honey, molasses, caramel, butterscotch, butter pecan,ginger, sassafras, hot pepper, soda (cola, root beer, sprite, gingerale, cream soda, Dr. Pepper and/or the like) and/or the like. Virtuallyany type of a desired flavor or flavoring, or a combination thereof, maybe employed.

The flavorings that may be employed in the base compositions and activeagent-containing compositions of the invention may be naturalflavorings, for example, a vanilla flavoring procured from vanillabeans, peppermint flavoring procured from a peppermint plant, spearmintflavoring procured from a spearmint plant, wintergreen flavoringprocured from a creeping wintergreen or teaberry plant, lemon flavoringprocured from a lemon or lemon peel, ginger flavoring procured from aginger plant or root, sassafras flavoring procured from the dried rootbark of a sassafras tree, or synthetic or artificial flavorings, orextracts, such as an almond extract. All of the foregoing types offlavorings may be obtained by methods that are known by those havingordinary skill in the art or are commercially available from sourcesthat are known by those having ordinary skill in the art, for example,from Bell Flavors & Fragrances Inc. (Northbrook, Ill.), InternationalFlavors and Fragrances (New York, N.Y.) and the Spice Barn (LewisCenter, Ohio).

The amount (combined) of one or more flavorings that is optionallypresent in the active agent-containing compositions of the invention isan amount that is effective to cause these compositions to: (i) have apleasant or desirable, or a specific, taste and/or odor, such as a goodand/or desirable vanilla taste and odor; (ii) have no, a reduced, or aminimal, unpleasant taste and/or odor (in comparison with how the tasteand/or odor would have been if no flavoring(s) had been included in thecompositions), such as a reduction of a bitter taste and/or odor thatwould otherwise have been present as a result of an inclusion ofhydrocortisone in the compositions; or (iii) have no taste and/or noodor.

Original Active Agent-Containing Compositions

When present in the original active agent-containing compositions, theamount (combined) of one or more flavorings that is present thereinpreferably ranges from about 0.1 to about 3.5 weight percent, and morepreferably ranges from about 0.2 to about 3 weight percent, and evenmore preferably ranges from about 0.3 to about 2 weight percent, andstill more preferably ranges from about 0.4 to about 1 weight percent.

Improved Active Agent-Containing Compositions

When present in the improved active agent-containing compositions, theflavoring(s), such as vanilla flavorings, preferably is present thereinin an amount (combined) preferably ranging from about 0.1 to about 3.5weight percent, and more preferably ranging from about 0.1 to about 2.5weight percent, and still more preferably ranging from about 0.3 toabout 1.5 weight percent, and is most preferably about 0.5 weightpercent.

Additional information about flavorings is present, for example, inVirginia Lanzotti et al., “Flavour and Fragrance Chemistry (Proceedingsof the Photochemical Society of Europea) (Springer, 1st edition,ISBN-10: 079236211X, 2000); Carol Schiller et al., “The AromatherapyEncyclopedia: A Concise Guide to over 385 Plant Oils” (Basic HealthPublications, 1st Edition, ISBN-10: 1591202280, 2008); and OrlindoSecondini, “Handbook of Perfumes and Flavors” (Chemical PublishingCompany, ISBN-10: 0820603341, 1990).

Other Optional Ingredients

The base compositions and active agent-containing compositions of theinvention may, in some cases, optionally, contain one or more other(additional or substitute) active or inactive ingredients, such asvarious vitamins, minerals, antioxidants, anti-inflammatory agents,antibiotic agents, antibacterial agents, antiviral agents, whiteningagents, dispersing agents, thickening agents (xanthan gum, guar gum, gumarabic, methylcellulose, sodium carboxymethyl cellulose, carrageenan,starch and the like), anti-itch agents, polymers, pigments, cellactivating agents, sunscreen agents, preservatives, colorants, collagen,glycerin, lecithin, talc, aloe vera, lanolin or other agents, forexample, vitamin E (

-tocopherol, β-tocopherol, γ-tocopherol, δ-tocopherol and the like).However, the compositions need not include any ingredients other thanthose that are described herein.

Various optional ingredients that may possibly be employed in the basecompositions and active agent-containing compositions of the inventionmay be described in, for example, “Cosmetic Additives—An IndustrialGuide” (William Andrew Publishing, 1991), “Cosmetic and ToiletryFormulations” (Volume 3, 2^(nd) Edition, William Andrew Publishing,1995), “Handbook of Cosmetics and Personal Care” (Gower PublishingUnlimited, ISBN 0566074702, 1994), “Cosmetic Ingredients” (Three RiversPress, ISBN 0609803670, 1999) and “Cosmetics Unmasked” (Thorsons, HarperCollins, ISBN 0-00-710568-1, 2001), and/or may be commercially availablefrom Base Formula, Ltd. (Melton Mowbray, England), Well NaturallyProducts, Ltd. (Blaine, Wash.), Essential Wholesale (Clackamas, OR),Urist Cosmetics, Inc. (Richmond, Calif.) and/or Sciencelab.com, Inc.(Houston, Tex.). Those having ordinary skill in the art may determinethe weight percents of one or more optional ingredients that may beemployed in the base compositions and active agent-containingcompositions of the invention, and how to vary the other ingredientspresent therein accordingly.

Optional ingredients that may possibly be included in the basecompositions and active agent-containing compositions of the presentinvention include, but are not limited to, the ingredients that areidentified below, and suitable amounts thereof, which may readily bedetermined by those having ordinary skill in the art.

Glycols Glycerin Propylene Glycol Butylene Glycol Hexylene Glycol2-Methyl Propane Diol Other Alcohols Ethanol Isopropanol n-propanollauryl alcohol oleyl alcohol Esters Isopropyl Myristate IsopropylPalmitate Jojoba Oil Glyceryl tri caprate/caprylate Butyl AcetatePropylene Glycol di Caprate/Caprylate Sorbitan Esters Diesters ofDiacids Ethyl Acetate Ethoxylated Materials Ethoxylated Fatty AlcoholsEthoxylated Fatty Acids Ethoxylated Sorbitan Esters EthoxylatedGlycerides Ethoxydiglycol Ketones Acetone Methyl Ethyl Ketone OtherWaxes/Bases Lubragels Zigels Jojoba Glaze Absorption Bases AliphaticCompounds n-alkanes branched alkanes Permethyls Propoxylated MaterialsPropoxylated Fatty Alcohols Propoxylated Fatty Acids Esters ofPropoxylated Fatty Alcohols Ethoxylated Propoxylates Aerosol PropellantGases Anhydrous Ionic Surfactants Phosphate Esters Sulfates CarboxylatesFatty Amine Salts Quaternary Nitrogen Salts Other Fats, Oils and WaxesDerived from Animals, Minerals, Marine or Other Sources SiliconesDimethicone Simethicone Cyclomethicone Dimethicone Ethoxylates andPropoxylates Fluorocarbons and Derivatives Zonyls Fluorocarbon AlcoholsAmides Fatty Acid Diethanolamides Fatty Acid Monoethanolamides FattyAcid Dimethylaminopropyl Amides Polymers Polyalkenes PolyoxyethylenesPolyoxypropylenes Polyamides Polyesters Polyurethanes Cellulostics andDerivatives Copolymers

Most Preferred Active Agent-Containing Compositions

Two of the most preferred original active agent-containing compositionsof the present invention, and two of the most preferred improved activeagent-containing compositions of the present invention, contain theingredients that are set forth below, and the weight percents thereof(of the 100% total weight of the composition), and preferably do notinclude any different or additional ingredients, and are produced in theform of a solid cylinder (stick), such as a traditional ChapStick® form,but in various sizes, for example, in the two different sizes that areillustrated in FIG. 1, and in a form that is contained in a pot, jar orcan. The first original formulation includes a flavoring, and is themore preferred of the two, and the second formulation does not includeany flavoring (and the weight percent of the Castor Oil is increased bythe same weight percent that is missing with respect to the missingflavoring to compensate for the absent flavoring, which may also be donewith other absent formulation ingredients). This is the same case withthe two improved formulations. These compositions have all beendetermined via topical skin application testing on human beings, as isdiscussed in the “Examples” section, and as is illustrated in FIGS.2-17, to be extremely efficacious for deeply penetrating, conditioningand healing, various layers of, and tissues present in, the skin ofhuman beings, including the dermis and epidermis, in connection withvarious skin disorders, diseases and conditions of human beings, as aredescribed herein, and for maintaining their forms, shapes andconsistencies under adverse environmental conditions.

Original Active Agent-Containing Formulations

Ingredient Weight Percent Hydrocortisone 1.0 FANCOL VB 11.0 NatunolaCastor 1023 18.0 Finsolv TN 11.0 Bees Wax 20.0 Castor Oil 11.5 StearylAlcohol 20.0 Cocoa Butter 7.0 Flavoring (Vanilla) 0.5 TOTAL 100

Ingredient Weight Percent Hydrocortisone 1.0 FANCOL VB 11.0 NatunolaCastor 1023 18.0 Finsolv TN 11.0 Bees Wax 20.0 Castor Oil 12.0 StearylAlcohol 20.0 Cocoa Butter 7.0 Flavoring (Vanilla) 0.0 TOTAL 100

Improved Active Agent-Containing Formulations

Ingredient Weight Percent Hydrocortisone 1.0 FANCOL VB 11.00 NatunolaCastor 1023 10.00 FINSOLV TN 15.00 Bees Wax 11.00 Castor Oil 24.50Stearyl Alcohol 20.00 Cocoa Butter 7.00 Flavoring (Vanilla) 0.50 TOTAL100

Ingredient Weight Percent Hydrocortisone 1.0 FANCOL VB 11.00 NatunolaCastor 1023 10.00 FINSOLV TN 15.00 Bees Wax 11.00 Castor Oil 25.00Stearyl Alcohol 20.00 Cocoa Butter 7.00 Flavoring (Vanilla) 0.0 TOTAL100

Preparation of Compositions

The base compositions and active-agent containing compositions of theinvention (whether or not including one or more active agents) arepreferably prepared in the manner that is described below, or elsewhereherein, preferably employing the specified order of steps and processconditions identified therein (amounts, times, temperatures, mixing andthe like), but may be prepared using other methods that producecompositions having the features and/or characteristics that aredescribed herein, using customary equipment that is known by thosehaving skill in the art for preparing topical skin products or otherequipment.

Although the methods that are described below (and elsewhere herein)refer to the active agent hydrocortisone, other active agents can beused in these methods in addition to, or alternatively to,hydrocortisone (in the same or similar manner described). Thehydrocortisone (and/or other active agent(s)) may be physically combinedwith the base composition that is described herein to achieve theconcentrations that are described herein by stirring together, orotherwise mixing or combining, the individual components in the mannerthat is described herein (preferably with continuous mixing).Preferably, sufficient agitation to achieve relative homogeneity of thevarious ingredients in the compositions is employed. Agitation may beachieved, for example, using a standard (or other) mixer, at a slow,moderate or even vigorous speed. Using the information that is providedherein, those having ordinary skill in the art will be able to varythese methods and compositions in a manner desired or required under aparticular set of circumstances or to produce a particular basecomposition or active agent-containing composition of the invention.

To prepare the original base and active-agent formulations of theinvention, an amount (combined) of one or more plant oils or plant seedoils, such as castor oil, that is sufficient for producing an effectivebase or active agent-containing composition of the invention in a formthat may properly be filled into a suitable container or packaging, andtopically applied to the skin of a mammal, with the amount thereofpossibly varying widely depending upon the size of the batch of thecomposition being produced, which may be determined by those havingordinary skill in the art and, as one example may be about 11.5 g, isoptionally added to a standard stainless steel drum including a mixerand heated using a conventional hot plate to a temperature that iseffective for evenly heating the plant oil(s) and/or plant seed oil(s)in the drum, which generally ranges from about 75° C. to about 85° C.,while stifling it continuously using the mixer.

An amount of FANCOL VB that is sufficient for producing an effectivecomposition of the invention in a form that may be properly filled intoa suitable container or packaging, and topically applied to the skin ofa mammal, with the amount of FANCOL VB possibly varying widely dependingupon the size of the batch of the composition being produced, which maybe determined by those having ordinary skill in the art and, as oneexample may be about 11.0 g, is then added to the plant oil(s) and/orplant seed oil(s) in the drum (if present), and mixed with therewithuntil it is preferably completely dissolved therein, which generallytakes from about 30 to about 45 minutes, while maintaining a temperaturethat is effective for preferably evenly heating the mixture andcompletely dissolving the FANCOL VB in the oil(s), which generallyranges from about 75° C. to about 85° C. If no plant oil(s) or plantseed oil(s) are employed in the first step, the FANCOL VB is added tothe steel drum and heated using a conventional hot plate to theforegoing temperature, which is effective for evenly heating the FANCOLVB in the drum

An amount of Natunola Castor 1023 that is sufficient for producing aneffective composition of the invention in a form that may be properlyfilled into a suitable container or packaging, and topically applied tothe skin of a mammal, with the amount of Natunola Castor 1023 possiblyvarying widely depending upon the size of the batch of the compositionbeing produced, which may be determined by those having ordinary skillin the art and, as one example may be about 18.0 g, is then added to theabove product, such as a mixture of plant oil(s) and/or plant seedoil(s) and FANCOL VB, in the drum while a temperature that is effectivefor preferably evenly heating the mixture and dissolving the NatunolaCastor 1023 therein is maintained, which generally ranges from about 75°C. to about 85° C. Mixing is then preferably continued for a period oftime that is sufficient to completely dissolve the Natunola Castor 1023therein, which typically ranges from about 30 to about 60 minutes.

An amount of bees wax that is sufficient for producing an effectivecomposition of the invention in a form that may be properly filled intoa suitable container or packaging, and topically applied to the skin ofa mammal, with the amount of bees wax possibly varying widely dependingupon the size of the batch of the composition being produced, which maybe determined by those having ordinary skill in the art and, as oneexample may be about 20.0 g, is added to the above mixture in the drumwhile a temperature that is effective for preferably evenly heating themixture and dissolving the bees wax therein is maintained, thattemperature generally ranging from about 75° C. to about 85° C. Mixingis preferably continued for a period of time that is sufficient tocompletely dissolve the bees wax therein, which typically ranges fromabout 30 to about 45 minutes.

An amount (combined) of one or more fatty alcohols, such as stearylalcohol, that is sufficient for producing an effective composition ofthe invention in a form that may be properly filled into a suitablecontainer or packaging, and topically applied to the skin of a mammal,with the amount of the fatty alcohol(s) possibly varying widelydepending upon the size of the batch of the composition being produced,which may be determined by those having ordinary skill in the art and,as one example may be about 20.0 g, is then optionally added to theabove mixture in the drum while a temperature that is effective forpreferably evenly heating the mixture and dissolving the fattyalcohol(s) therein is maintained, that temperature generally rangingfrom about 75° C. to about 85° C. If fatty alcohol(s) are added, mixingis preferably continued for a period of time that is sufficient tocompletely dissolve the fatty alcohol(s) therein, which typically rangesfrom about 30 to about 45 minutes.

An amount (combined) of one or more fats, such as cocoa butter, that issufficient for producing an effective composition of the invention in aform that may be properly filled into a suitable container or packaging,and topically applied to the skin of a mammal, with the amount of thefat(s) possibly varying widely depending upon the size of the batch ofthe composition being produced, which may be determined by those havingordinary skill in the art and, as one example may be about 7.0 g, isoptionally added to the above mixture in the drum while a temperaturethat is effective for preferably evenly heating the mixture anddissolving the fat(s) therein is maintained, that temperature generallyranging from about 75° C. to about 85° C. If fat(s) are added, mixing ispreferably continued for a period of time that is sufficient tocompletely dissolve the fat(s) therein, which typically ranges fromabout 30 to about 45 minutes.

An amount of Finsolv TN that is sufficient for producing an effectivecomposition of the invention in a form that may be properly filled intoa suitable container or packaging, and topically applied to the skin ofa mammal, with the amount of Finsolv TN possibly varying widelydepending upon the size of the batch of the composition being produced,which may be determined by those having ordinary skill in the art and,as one example may be about 11.0 g, is added to the above mixture in thedrum while a temperature that is effective for preferably evenly heatingthe mixture and dissolving the Finsolv TN therein is maintained, thattemperature generally ranging from about 75° C. to about 85° C. Mixingis preferably continued for a period of time that is sufficient tocompletely dissolve the Finsolv TN therein, which typically ranges fromabout 30 to about 45 minutes.

The above mixture is preferably mixed for an additional period of timethat is sufficient to have any remaining particles present thereinpreferably be completely dissolved in the mixture, which generallyranges from about 30 to about 60 minutes, while a temperature that issufficient to dissolve such particles in the mixture is preferablymaintained, which generally ranges from about 75° C. to about 85° C.

If the composition being produced is an active-agent containingcomposition, the resulting mixture is then preferably permitted to cool(naturally or using conventional cooling equipment, such as arefrigerator) to a temperature that is effective for mixinghydrocortisone (and/or other active ingredient(s)) therewith in a mannerthat does not render the hydrocortisone (and/or other activeingredient(s)) ineffective or significantly less effective than it wasin its original form (i.e., prior to adding it to the above mixture),which typically ranges from about 55° C. to about 60° C.

An amount of hydrocortisone (and/or other active ingredient(s)) that issufficient for producing an effective active agent-containingcomposition of the invention in a form that may be properly filled intoa suitable container or packaging, and topically applied to the skin ofa mammal, with the combined amount of the hydrocortisone and/or otheractive ingredient(s) possibly varying widely depending upon the size ofthe batch of the composition being produced, which may be determined bythose having ordinary skill in the art and may be, as one example about1.0 g, is then added to the above mixture and mixed therewith preferablyuntil it is dissolved while maintaining the temperature of the mixtureat the above temperature (i.e., preferably ranging from about 55° C. toabout 60° C.), which typically takes from about 30 to about 45 minutes.

The resulting mixture (not including any active ingredient(s) for a basecomposition or including one or more active ingredient(s) for an activeagent-containing composition) is then permitted to cool (naturally orusing conventional cooling equipment, such as a refrigerator) to atemperature that is effective for optionally incorporating one or moreflavorings therein in a manner that preferably does not render theflavoring less flavorful or less aromatic, or substantially lessflavorful or less aromatic, than it was originally (i.e., prior toincorporating it therein), which generally ranges from about 50° C. toabout 55° C., and then the flavoring(s) is added to the mixture. Theflavoring(s), if added, is preferably mixed with the mixture for aperiod of time that is sufficient to incorporate it evenly throughoutthe mixture, which generally ranges from about 15 to about 20 minutes,while preferably maintaining a temperature that is effective forpermitting such even distribution of the flavoring in the mixture, thattemperature generally ranging from about 50° C. to about 55° C.

At this point in the above process, the resulting mixture willpreferably be liquid in nature, and may have a light yellow color and ageneral appearance of a thin, milky liquid. For active agent-containingcompositions, a sample of the resulting mixture is then preferablyanalyzed using standard techniques known by those having ordinary skillin the art, such as High Performance Liquid Chromatography (HPLC) or GasChromatography (GS), to determine the concentration of the activeagent(s) that is present in the mixture, as one example, 1 weightpercent of hydrocortisone.

For the active agent-containing compositions, once the sample is foundto be acceptable (i.e., to possess the above characteristics and thedesired concentration of the active agent(s) therein), the entire batchof the composition is preferably transferred to a filler assembly line,where it is poured or otherwise transferred (manually, robotically orotherwise) into individual (or other) containers or molds of any desiredsize, shape and/or other characteristics, to preferably form a solid,preferably in a cylindrical shape, such as those that are illustrated inFIG. 1, or a traditional ChapStick® type (or other) stick. Standardfilling equipment that is known by those having ordinary skill in theart may be used for this step.

A wide variety of plastic, glass, metal and other types and materials ofcontainers, cases, pouches, bottles, jars, squeezable (or other) tubes(lip balm, roll-on, roll-up and/or the like), vials, boxes, bags, pots,tins, cans, lids, other closures, and/or the like, having a wide varietyof different sizes, shapes, colors and/or other physical attributes, andmade from a wide variety of different materials, or combinationsthereof, which may be used to removably or irremovably contain or housethe compositions are available from sources that are known by thosehaving ordinary skill in the art, such as from SKS Bottle and Packaging,Inc. (Watervliet, N.Y.). For example, the compositions may be present inindividual containers that form around, house or contain a solid in ashape of a stick, as is shown in FIG. 1, which may be partially or fullyremoved from the container for use by a user by exerting a twisting orturning action of the end of the container that does not include theclosure (lid, cap or the like). Alternatively, they may be present inlip gloss sized and types of pots or jars, and do not become removedfrom the containers by a user when being used, and/or the like.

After the compositions settle, and possibly harden into solid forms, inthe containers, which generally takes a period of time ranging fromabout 60 to about 120 minutes, a container cap is preferably applied tothe open end of each container, preferably along with a label includingidentifying and/or other information, such as a lot code.

The resulting product is then preferably individually packaged usingconventional packaging equipment known by those having ordinary skill inthe art, or otherwise, into required or desired packaging of any type,which may or may not be tamper-evident and/or childproof, such as apaper or cardboard box, an aluminum or plastic pouch or sheath, and/orthe like. Alternatively, or in addition, tamper-evident and/orchildproof plastic and/or other material may be placed, formed, wrappedand/or sealed around the cap (or other) area(s) of the container in amanner that indicates (to a consumer) tampering of the container whentorn, perforated or otherwise damaged or disrupted.

The improved base and active-agent formulations of the invention may beprepared in a similar manner using the same or similar steps andconditions. However, it is preferred that such formulations be preparedby adding the various ingredients in the following order, rather than inthe order described above, with mixing until the various ingredients arefully dissolved within the prior-listed ingredients:

-   -   (1) Castor Oil (Plant Oil);    -   (2) FANCOL VB;    -   (3) Bees wax;    -   (4) Stearyl Alcohol (Fatty Alcohol);    -   (5) Cocoa Butter (Fat);    -   (6) Finsolv TN;    -   (7) Natunola 1023;    -   (8) Hydrocortisone (Active Ingredient); and    -   (9) Flavor Ingredient(s).

Application and Application Rates

The base compositions and active-agent containing compositions of theinvention, such as those including hydrocortisone and/or other activeingredients, and the related methods, can be employed by physicians,such as dermatologists, nurse practitioners, nurses, other skin careprofessionals, veterinarians, and/or the like, as well as by lay (orother) individuals, to repair, improve, partially heal (i.e., having ahealing of the skin that is greater than about 0% but less than about100% in comparison with the condition of the skin just prior to a firstapplication of a composition of the invention to the skin) or fully heal(i.e., having a healing of about 100%) a wide variety of different skindisorders, diseases and adverse conditions, as are described herein (orotherwise), of the skin of a mammal and/or to produce or increase someother benefit to the skin.

An improvement in (greater than 0%, but less than 100%, repair orhealing), or a full (100%) healing of, the skin of a mammal that hasbeen treated with a composition of the invention may be detected in avariety of different manners, such as by a visually observable orotherwise detectable (by palpitation, touch, feel, smell and/or thelike) improvement in the morphology, tone, texture and/or appearance ofthe skin of the mammal, including, but not limited to, a reduction orelimination in the quantity and/or severity of pain, discomfort,soreness, burning, itching, inflammation, redness (or otherdiscoloration), bruising, bumps, blisters, cracking, cuts, perforations,punctures, other wounds, dryness or other defects, deformations and/orconditions, and/or the like. In addition, or alternatively, to beingdetected visually or manually, such an improvement may also be detectedby questioning a patient for, example, to determine whether or not lesspain and/or discomfort is present or experienced by the patent, or byusing a wide variety of different dermatologic and/or other medicaldevices, tests and/or equipment, which are known by those havingordinary skill in the art, such as photographic analysis, grading scalesrelated to psoriatic and eczematous disease such as, but not limited to,the PASI (Psoriasis Area and Severity Index) and EASI (Eczema Severityand Severity Index) scores, and visual observation. As is illustrated inthe accompanying drawings, photographic, visual observation or othercomparisons may readily be made between a mammal's skin, as it existedprior to initiating a first treatment thereof with a composition of theinvention, and as it existed at the termination of such treatment, or atany point or time in between the two.

The compositions of the invention that include one or more activecomponents may be applied to different areas of the skin of a mammaldirectly or indirectly in any convenient or desired manner, such as byrolling it directly upon the skin using a plastic or metal (or other)roll-up applicator, as is shown in FIG. 1, or roll-on applicator, likethose used to apply deodorant to the skin, indirectly by using one ormore fingers to brush or sweep across the surface of the compositions,such as when they are present in a roll-up applicator, a roll-onapplicator, a lip gloss type of a pot or jar, a spray, foam or othercan, or the like, and then using the fingers to apply the compositionsto the skin using rubbing, sweeping, patting or other actions. Thesecompositions may be applied to any sized area of the skin including, butnot limited to, an area the size of a pinpoint (or smaller) to an areathat spans one or a plurality of square centimeters, inches or even feet(or larger). As a general rule, the larger the area to be treated, thelarger a roll-up or roll-on or other applicator should be (for ease andspeed of application).

The active agent-containing compositions may be distributed to, orotherwise applied to, the skin, using a variety of different types ofapplicators and may, optionally, be externally or internally heated by aheating device, such as an electrical current from a battery or similardevice, to elevate the temperature of the compositions prior to anapplication to the skin, for example, from ambient temperature to atemperature ranging from about 5° C. (9° F.) to about 10° C. (18° F.)above ambient temperature (or higher) upon application or desire toapply. If the temperature of the composition is elevated to one that isat, or greater than, the melting point of the composition, a portion orall of the composition may become transformed by melting from a “solid”form to a “semi-solid” form or “liquid.” Such an elevated temperaturemay cause a “solid” composition to partially or fully melt and becometransformed into a “semi-solid” or even a liquid, and applied to theskin of a mammal in such transformed form. An elevated temperature thatis below the melting point of the composition may cause the compositionto become softened or more pliable. A separated chamber of a containerhousing the composition may or may not contain the composition to besoftened or melted prior to application to the body and/or lips. Theability to push the composition to this potential separate chamber maybe controlled, for example, by a small aperture in the composition whichcould be small enough to push composition through upon revolution of thecomposition chamber below and pressure upward. This chamber could thenbe heated selectively, allowing the composition below it to remain inits non-melted form. The ability to heat it would be controllable by,for example, a button-device on the side of the chamber. It is alsopossible to alter the amounts of the compositions that are delivered tothe skin at one time by sealing off a device delivery system from theactual composition below, thereby reducing the potential contaminationof the product below the area touching the skin or lips.

The compositions of the invention that include hydrocortisone and/or oneor a plurality of other active agents are preferably applied directly orindirectly to the skin of a mammal in an amount, and for a number ofapplications, that are effective for causing or providing: (i) a repairof, or an improvement in, the mammal's skin in some manner and/orpartially or fully healing one or more disorders, diseases, adverse (orother) conditions, maladies and/or the like of the mammal's skin, forexample, a decrease in inflammation, swelling, irritation, burning,itching, redness, pain, soreness, extreme (or other) dryness, bumps,blisters, itching, cracking, acne excoriae, insect bite size, wound sizeand/or the like, as are described herein or otherwise; and/or (ii) areduction in pain, soreness, discomfort, itchiness and/or the like,and/or an increase in a soothing, softening, conditioning and/or thelike, of the mammal's skin.

The total amount of the hydrocortisone (and/or other active agent)formulation of the invention that is effective for improving the skin insome manner and/or for partially or fully healing one or more skinconditions, disorders, diseases, maladies and/or the like, as aredescribed herein (or otherwise), may vary widely, depending upon avariety of factors, such as the type, age, sex, genetic predispositionand general health of the mammal being treated, whether the mammal is ahuman or non-human mammal, the amount of the mammal's exposure toadverse or harsh environmental conditions, such as the sun, wind, heatand/or cold, the particular active agent, or combination of activeagents employed, the particular formulation employed, the particularcondition(s), disorder(s), disease(s), malady(s) and/or the like beingtreated, and/or the like, and may readily be determined by those havingordinary skill in the art using the information that is provided herein.

The amount of an active agent-containing composition of the inventionthat will generally be effective for achieving or obtaining one or moreof the goals that are described herein may readily be determined bythose having ordinary skill in the art. The quantity of such acomposition to be administered to a mammal for each application, and thenumber of applications to be applied, depend upon the nature of thecomposition, the condition(s) being treated and the area(s) of the bodyinvolved, and may be determined by those having ordinary skill in theart using the information contained herein. With that being said, theamount of a composition that is applied to the skin of a mammal per eachapplication preferably ranges from about 1 to about 20 g or ml, and morepreferably ranges from about 2 to about 12 g or ml, and still morepreferably ranges from about 3 to about 8 g or ml, and even still morepreferably ranges from about 4 to about 6 g or ml, with about 5 g or mlbeing most preferred. For example, about 5 g of the composition may beapplied to the skin of a mammal from a suitable container or applicatorand spread over, or rubbed into, the skin using the hands or fingers ora suitable application or other device. However, such amounts can varywidely, with the lowest quantity generally being an amount that renderssome improvement in the skin (either alone or in a series of multipleapplications), with there not being an upper limit to the largestquantity (other than safety concerns). Although there generally is noupper limit to the quantity of composition that can be applied perapplication, above a certain quantity, no further improvement in themammal's skin may be observed or otherwise detected.

The following types and sizes of applicators for compositions within theinvention were used in the experiments that are described in Examples6-9 hereinbelow.

-   -   (i) a 0.15 fluid ounce stick-shaped roll-up skin balm measuring        about 6.0 cm in length and about 1.5 cm in diameter (a suitable        size for a lip and face balm—a small stick);    -   (ii) a 0.50 fluid ounce stick-shaped roll-up skin balm measuring        about 7.6 cm in length and about 2.0 cm in diameter (a suitable        size for a body balm—a large stick); and    -   (iii) a 0.25 fluid ounce jar-shaped skin balm measuring about        3.0 cm in length and about 3.3 cm in diameter (a suitable size        for a face balm—a pot or jar).        In these or other experiments, about 0.1 g or ml of composition        was delivered to a patient per application using the small        stick, about 0.5 g or ml of composition was delivered to a        patient per application using the large stick, and about 0.15 g        or ml of composition was delivered to a patient per application        using the pot or jar. However, such quantities to be delivered        per application can be decreased or increased, as is desired or        required by a user, by rolling (or otherwise applying) the        stick(s) (or other application device) over smaller or larger        areas of the skin per application and/or by decreasing or        increasing the number of times that the stick(s) (or other        application device) is rolled (or otherwise applied) over the        same or different areas of the skin per application.

Thus, as only by way of some examples, the following quantities ofcompositions within the present invention, or others, may beadministered to a user per application (in g or ml), as well as anyquantities in between:

-   -   0.01. 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2,        0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5,        1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8,        2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1,        4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4,        5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7,        6.8, 6.9. 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 8.0.        8.1, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 8.8, 8.9, 9.0. 9.1, 9.2, 9.3,        9.4, 9.5, 9.6, 9.7, 9.8, 9.9, 10.0, 10.1, 10.2, 10.3, 10.4,        10.5, 10.6, 10.7, 10.8, 10.9, 11.0, 11.1, 11.2, 11.3, 11.4,        11.5, 11.6, 11.7, 11.8, 11.9, 12.0, 12.1, 12.2, 12.3, 12.4,        12.5, 12.6, 12.7, 12.8, 12.9, 13.0, 13.1, 13.2, 13.3, 13.4,        13.5, 13.6, 13.7, 13.8, 13.9, 14.0, 14.1, 14.2, 14.3, 14.4,        14.5, 14.6, 14.7, 14.8, 14.9, 15.0, 15.1, 15.2, 15.3, 15.4,        15.5, 15.6, 15.7, 15.8, 15.9, 16.0, 16.1, 16.2, 16.3, 16.4,        16.5, 16.6, 16.7, 16.8, 16.9, 17.0, 17.1, 17.2, 17.3, 17.4,        17.5, 17.6, 17.7, 17.8, 17.9, 18.0, 18.1, 18.2, 18.3, 18.3,        18.4, 18.5, 18.6, 18.7, 18.8, 18.9, 19.0, 19.1, 19.2, 19.3,        19.4, 19.5, 19.6, 19.7, 19.8, 19.9, 20.0, 20.1, 20.2, 20.3,        20.4, 20.5, 20.6, 20.7, 20.8, 20.9, 21, 22, 23, 24, 25, 26, 27,        28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40 and so forth.

The number of applications of a composition to the skin of a mammal thatwill generally be effective for producing one or more desired effects,as are described herein, and the period of time during which suchapplications are made, may vary widely, depending upon a variety offactors, such as the concentration of the one or more active agents thatare present in the composition, the amount of the composition that isapplied to the mammal's skin, the condition of the mammal's skin, theamount of the mammal's sun exposure and the type, age, sex, geneticpredisposition and general health of the mammal, and may readily bedetermined by those having ordinary skill in the art using theinformation provided herein. While the skin of a mammal may exhibit someimprovement after only one application of a composition thereto, inorder to obtain a more pronounced or full effect or benefit, it istypically beneficial to provide two or more applications to the mammal'sskin, and more typically beneficial to provide at least about threeapplications of the composition to the skin of the mammal (three, four,five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen,fifteen, sixteen, seventeen, eighteen, nineteen, twenty, twenty-one,twenty-two, twenty-three, twenty-four, twenty-five, twenty-six,twenty-seven, twenty-eight, twenty-nine, thirty and so forthapplications) continuously over a period of at least about one day orweek, or a series of days or weeks (one, two, three, four, five, six,seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen,sixteen, seventeen, eighteen, nineteen, twenty, twenty-one, twenty-two,twenty-three, twenty-four, twenty-five, twenty-six, twenty-seven,twenty-eight, twenty-nine, thirty and so forth days or one, two, three,four, five, six, seven, eight, nine, ten, eleven, twelve, and so forthweeks). The compositions may, for example, be applied as a solid stick(or other solid form), a cream, a gel, a lotion, an ointment or otherconvenient form as frequently as once per 15 minutes (or per fewerminutes, such as 1, 5 or 10 minutes) and as infrequently as once per dayor so or on an “as needed” basis (i.e., applied as believed to benecessary or desirable, or required, typically depending upon the typesand severity of symptoms).

Usually, the greater the number of applications of the composition tothe skin of a mammal within a given period of time, such as a period ofone week, the greater an improvement will be observed or otherwisedetected in the mammal's skin, and the less time will be required forachieving such results. Although there generally is no upper limit tothe number of applications of the composition that can be applied to theskin of a mammal, above a certain number of applications, no furtherimprovement in the mammal's skin may be observed or otherwise detected.It will typically not be recommended to apply the compositions to theskin of a mammal more than about 48 times within a one-day (24 hour)period.

The table below shows examples of some of the application protocols thatcan be employed with the hydrocortisone and other activeagent-containing compositions of the invention at concentrations thatare described herein.

Examples of Application Protocols

Number of Applications Number of Days 1 time each day 1, 2, 3, 4, 5, 6,7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25,26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43,44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61,62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79,80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97,98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112,113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126,127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140,141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154,155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168,169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182,183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196,197, 198, 199, 200, 201, 202, 203, 204, 205, 206, 207, 208, 209, 210,215, 220, 250, 230 and so forth (more days) 2 times each day 1, 2, 3, 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23,24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41,42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59,60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77,78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95,96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110,111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124,125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138,139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152,153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166,167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180,181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193, 194,195, 196, 197, 198, 199, 200, 201, 202, 203, 204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 3 times each day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20,21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38,39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56,57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74,75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92,93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108,109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122,123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136,137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150,151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164,165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178,179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192,193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203, 204, 205, 206,207, 208, 209, 210, 215, 220, 250, 230 and so forth (more days) 4 timeseach day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18,19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36,37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54,55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72,73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90,91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106,107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120,121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134,135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148,149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162,163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176,177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190,191, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203, 204,205, 206, 207, 208, 209, 210, 215, 220, 250, 230 and so forth (moredays) 5 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50,51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68,69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86,87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103,104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117,118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131,132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145,146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159,160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173,174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187,188, 189, 190, 191, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201,202, 203, 204, 205, 206, 207, 208, 209, 210, 215, 220, 250, 230 and soforth (more days) 6 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29,30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47,48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65,66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83,84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100,101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114,115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128,129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142,143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156,157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170,171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184,185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196, 197, 198,199, 200, 201, 202, 203, 204, 205, 206, 207, 208, 209, 210, 215, 220,250, 230 and so forth (more days) 7 times each day 1, 2, 3, 4, 5, 6, 7,8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25,26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43,44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61,62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79,80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97,98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112,113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126,127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140,141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154,155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168,169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182,183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196,197, 198, 199, 200, 201, 202, 203, 204, 205, 206, 207, 208, 209, 210,215, 220, 250, 230 and so forth (more days) 8 times each day 1, 2, 3, 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23,24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41,42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59,60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77,78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95,96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110,111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124,125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138,139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152,153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166,167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180,181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193, 194,195, 196, 197, 198, 199, 200, 201, 202, 203, 204, 205, 206, 207, 208,209, 210, 215, 220, 250, 230 and so forth (more days) 9 times each day1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20,21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38,39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56,57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74,75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92,93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108,109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122,123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136,137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150,151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164,165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178,179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192,193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203, 204, 205, 206,207, 208, 209, 210, 215, 220, 250, 230 and so forth (more days) 10 timeseach day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18,19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36,37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54,55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72,73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90,91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106,107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120,121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134,135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148,149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162,163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176,177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190,191, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203, 204,205, 206, 207, 208, 209, 210, 215, 220, 250, 230 and so forth (moredays) 11 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50,51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68,69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86,87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103,104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117,118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131,132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145,146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159,160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173,174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187,188, 189, 190, 191, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201,202, 203, 204, 205, 206, 207, 208, 209, 210, 215, 220, 250, 230 and soforth (more days) 12 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29,30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47,48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65,66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83,84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100,101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114,115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128,129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142,143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156,157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170,171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184,185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196, 197, 198,199, 200, 201, 202, 203, 204, 205, 206, 207, 208, 209, 210, 215, 220,250, 230 and so forth (more days) 13 times each day 1, 2, 3, 4, 5, 6, 7,8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25,26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43,44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61,62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79,80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97,98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112,113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126,127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140,141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154,155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168,169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182,183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196,197, 198, 199, 200, 201, 202, 203, 204, 205, 206, 207, 208, 209, 210,215, 220, 250, 230 and so forth (more days) 14 times each day 1, 2, 3,4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22,23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40,41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58,59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76,77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94,95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109,110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123,124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137,138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151,152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165,166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179,180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193,194, 195, 196, 197, 198, 199, 200, 201, 202, 203, 204, 205, 206, 207,208, 209, 210, 215, 220, 250, 230 and so forth (more days) 15 times eachday 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19,20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37,38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55,56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73,74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91,92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107,108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121,122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135,136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149,150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163,164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177,178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191,192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203, 204, 205,206, 207, 208, 209, 210, 215, 220, 250, 230 and so forth (more days) 16times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34,35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52,53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70,71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88,89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104,105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118,119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132,133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146,147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160,161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174,175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188,189, 190, 191, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202,203, 204, 205, 206, 207, 208, 209, 210, 215, 220, 250, 230 and so forth(more days) 17 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13,14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31,32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49,50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67,68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85,86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102,103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116,117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130,131, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144,145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158,159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172,173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186,187, 188, 189, 190, 191, 192, 193, 194, 195, 196, 197, 198, 199, 200,201, 202, 203, 204, 205, 206, 207, 208, 209, 210, 215, 220, 250, 230 andso forth (more days) 18 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28,29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46,47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64,65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82,83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100,101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114,115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128,129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142,143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156,157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170,171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184,185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196, 197, 198,199, 200, 201, 202, 203, 204, 205, 206, 207, 208, 209, 210, 215, 220,250, 230 and so forth (more days) 19 times each day 1, 2, 3, 4, 5, 6, 7,8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25,26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43,44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61,62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79,80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97,98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112,113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126,127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140,141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154,155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168,169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182,183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196,197, 198, 199, 200, 201, 202, 203, 204, 205, 206, 207, 208, 209, 210,215, 220, 250, 230 and so forth (more days) 20 times each day 1, 2, 3,4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22,23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40,41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58,59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76,77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94,95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109,110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123,124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137,138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151,152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165,166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179,180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193,194, 195, 196, 197, 198, 199, 200, 201, 202, 203, 204, 205, 206, 207,208, 209, 210, 215, 220, 250, 230 and so forth (more days) 21 times eachday 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19,20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37,38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55,56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73,74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91,92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107,108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121,122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135,136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149,150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163,164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177,178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191,192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203, 204, 205,206, 207, 208, 209, 210, 215, 220, 250, 230 and so forth (more days) 22times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34,35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52,53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70,71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88,89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104,105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118,119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132,133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146,147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160,161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174,175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188,189, 190, 191, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202,203, 204, 205, 206, 207, 208, 209, 210, 215, 220, 250, 230 and so forth(more days) 23 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13,14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31,32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49,50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67,68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85,86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102,103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116,117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130,131, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144,145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158,159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172,173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186,187, 188, 189, 190, 191, 192, 193, 194, 195, 196, 197, 198, 199, 200,201, 202, 203, 204, 205, 206, 207, 208, 209, 210, 215, 220, 250, 230 andso forth (more days) 24 times each day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28,29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46,47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64,65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82,83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100,101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114,115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128,129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142,143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156,157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170,171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184,185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196, 197, 198,199, 200, 201, 202, 203, 204, 205, 206, 207, 208, 209, 210, 215, 220,250, 230 and so forth (more days) 25 times each day 1, 2, 3, 4, 5, 6, 7,8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25,26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43,44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61,62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79,80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97,98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112,113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126,127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140,141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154,155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168,169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182,183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196,197, 198, 199, 200, 201, 202, 203, 204, 205, 206, 207, 208, 209, 210,215, 220, 250, 230 and so forth (more days)

It is preferable, but not necessary, that the various applications ofthe composition of the invention that are applied each day be equallyspaced with a 24-hour period. For example, it is preferable that twoapplications that are to be applied in one day are applied approximately12 hours apart. It is preferable that three applications that are to beapplied in one day are applied approximately 8 hours apart. It ispreferable that four applications that are to be applied in one day areapplied approximately 6 hours apart. It is preferable that fiveapplications that are to be applied in one day are applied approximately4.8 hours apart, and so forth. It is also preferable that days not bemissed when a series of applications are to be made over a specifiednumber of days.

An improvement in an adverse (or other) skin condition, disease,disorder and/or the like of a mammal, and/or an improvement in one ormore characteristics of the mammal's skin generally, will very often beobserved or otherwise detected (via touch, a test and/or the like) assoon as one day after a first topical application of a composition ofthe invention thereto and no later than one week after such firstapplication. However, such times may vary depending upon a variety offactors, such as the type and severity of skin problem being treated,the age, sex and general health of the patient being treated, the amountof the active ingredient(s) present therein, and like factors, which maybe determined by those having ordinary skill in the art.

As an example, after a composition containing about 1 weight percent ofhydrocortisone (and/or one or more other active agents) is applied onetime per day to the skin of a mammal that requires, or could benefitfrom, skin treatment, an improvement in the condition of the skin willoften be observed or otherwise detected after a period of from about oneto about seven days. If the same composition is applied two times perday to the mammal's skin, an improvement in the condition of the skin ofthe mammal will often be observed or otherwise detected after a periodof from about one to about four days. If the same composition is appliedthree times per day to the mammal's skin, an improvement in thecondition of the mammal's skin will often be observed or otherwisedetected after a period of from about one to about three days. If thesame composition is applied four times per day to the mammal's skin, animprovement in the condition of the mammal's skin will often be observedor otherwise detected after a period of from about one to about twodays. If the same composition is applied five times per day to themammal's skin, an improvement in the condition of the mammal's skin willoften be observed or otherwise detected after a period of from about oneto about two days. More rapid results may likely be achieved whencompositions containing higher weight percents of the hydrocortisone(and/or other active agent), such as 2, 3, 4 or 5 weight percent of thehydrocortisone (and/or other active agent), are applied to the skin of amammal using the foregoing application rates. Typically, the higher theconcentration of the hydrocortisone (or other active agent) that ispresent in the compositions, the more rapid the beneficial resultsthereof will be observed or otherwise detected.

Sources of Ingredients

All of the ingredients, materials and equipment employed in the methodsof the invention are commercially available from sources known by thosehaving ordinary skill in the art, such as those that are describedhereinabove, and Botagenics, Inc. (Northridge, Calif.), Base Formula,Ltd. (Melton Mowbray, England), Well Naturally Products, Ltd. (Blaine,Wash.), Essential Wholesale (Clackamas, Oreg.), Urist Cosmetics, Inc.(Richmond, Calif.), Sciencelab.com, Inc. (Houston, Tex.), Fluka Chemicaland Biochemical Co. (Ronkonkoma, N.Y.), Sony North America (New York,N.Y.), NOVA Technology Corporation (Portsmouth, N.H.), ServoMed(Sweden), (Expo Engineered Inc., Cicero, Ill.) and LovelySkin (Omaha,Nebr.).

The following examples describe and illustrate the base compositions andactive agent-containing compositions, and methods, of the presentinvention. These examples are intended to be merely illustrative of thepresent invention, and not limiting thereof in either scope or spirit.Those having ordinary skill in the art will readily understand thatvariations of certain of the ingredients, amounts, conditions and/orsteps employed in the procedures described in the examples can beemployed.

All of the experimental testing of compositions within the presentinvention that is described in these examples was performed by, or underthe complete direction and control of, inventor and board certifieddermatologist and cosmetic surgeon Joel Schlessinger, MD, FAAD, FAACSwith patients having various skin maladies under confidential conditionsand circumstances in order to determine the efficacy of thesecompositions generally, and under different conditions, using differentapplication rates and/or different application devices, to treatdifferent medical skin disorders (cuts, cracks, peeling, eczema, rashes,irritation, dryness, excessive dryness and inflammation), and as appliedto different body parts (lips, cheeks, chin, face, fingers, hands and/orarms) of different human beings (those of different ages and sexes, andhaving different weights), and in comparison with different control orknown compositions.

EXAMPLE 1 Preparation of a Hydrocortisone Composition (Including VanillaFlavoring) Initial Formulation

A batch of a vanilla-flavored hydrocortisone-containing topical skinformulation of the present invention in the form of a roll-up balm wasprepared in the manner described below, and designated as batch LTC#6-47AHV. The composition contained the components, and weight percentsthereof, that are set forth below.

Ingredient Weight Percent Hydrocortisone 1.0 FANCOL VB 11.0 NatunolaCastor 1023 18.0 Finsolv TN 11.0 Bees Wax 20.0 Castor Oil 11.5 StearylAlcohol 20.0 Cocoa Butter 7.0 Flavoring (Vanilla) 0.5 TOTAL 100

11.5 g of castor oil was added to a standard stainless steel drumincluding a mixer and heated using a standard hot plate to a temperatureranging from about 75° C. to about 85° C., while stirring itcontinuously using the mixer.

11.0 g of FANCOL VB was added to the castor oil in the drum, and mixedwith the castor oil until it was completely dissolved therein, whichtook about 30 minutes, while maintaining a temperature ranging fromabout 75° C. to about 85° C.

18.0 g of Natunola Castor 1023 was added to the mixture of castor oiland FANCOL VB in the drum while a temperature ranging from about 75° C.to about 85° C. was maintained. Mixing of the ingredients was thencontinued for about 60 minutes.

20.0 g of bees wax was then added to the above mixture in the drum whilea temperature ranging from about 75° C. to about 85° C. was maintained.Mixing was continued for about 30 minutes, which was sufficient tocompletely dissolve the bees wax therein.

20.0 g of stearyl alcohol was then added to the above mixture in thedrum while a temperature ranging from about 75° C. to about 85° C. wasmaintained. Mixing was continued for a period of about 30 minutes, whichwas sufficient to completely dissolve the stearyl alcohol therein.

7.0 g of cocoa butter was then added to the above mixture in the drumwhile a temperature ranging from about 75° C. to about 85° C. wasmaintained. Mixing was continued for about 30 minutes, which wassufficient to completely dissolve the cocoa butter therein.

11.0 g of Finsolv TN was then added to the above mixture in the drumwhile a temperature ranging from about 75° C. to about 85° C. wasmaintained. Mixing was continued for a period of about 30 minutes, whichwas sufficient to completely dissolve the Finsolv TN therein.

The above mixture was mixed for an additional period of about 30-60minutes, which was sufficient to cause any remaining particles presenttherein be completely dissolved in the mixture, while a temperatureranging from about 75° C. to about 85° C. was maintained.

The resulting mixture was then permitted to cool naturally to atemperature ranging from about 55° C. to about 60° C.

1.0 g of hydrocortisone was then added to the above mixture and mixedtherewith until it dissolved therein, which took about 30 minutes, whilemaintaining the temperature of the mixture ranging from about 55° C. toabout 60° C.

The resulting mixture was then permitted to cool naturally to atemperature ranging from about 50° C. to about 55° C., and then 0.5 g ofvanilla flavoring was added to the mixture. The vanilla flavoring wasmixed with the mixture for about 15-20 minutes, which was sufficient toincorporate it evenly throughout the mixture, while maintaining atemperature ranging from about 50° C. to about 55° C.

The resulting mixture was liquid in nature, light yellow in color, andhad a general appearance of a thin milky liquid. A sample of thismixture was analyzed using High Performance Liquid Chromatography (HPLC)to determine the weight percentage of hydrocortisone in the mixture,which was determined to be 1 weight percent. (Gas chromatography (GS)may also be used to perform this function.)

Once the sample was found to be acceptable (i.e., to possess the abovecharacteristics), the entire batch of the composition was transferred toa filler assembly line, where it was manually poured into individualplastic container molds to form stick-shaped roll-up skin balmsmeasuring about 5.5 cm in length and about 1.5 cm in diameter.

After the compositions settled and hardened in the containers, whichgenerally took about 60 minutes, a plastic container cap was placed ontothe open end of each container. (While not done with respect to the skinbalms described in this example, a label including a batch code (orother information) may be placed onto one or a plurality of thecontainer tubes.)

Several other forms of a topical hydrocortisone-containing composition,but not including the particular ingredients that are described herein,or the particular percent weights thereof, were also produced in thesame, or a similar, manner as is described above. Many of these formswere not deemed to be acceptable because they were too thick (and didnot spread well on the skin), too bitter tasting, ineffective inimproving, repairing and/or healing one or more skin conditions ormaladies and/or exhibited one or more other unacceptablecharacteristics. For example, samples designated as 6-25A, 6-25B, 6-26A,6-26B, 6-16C, 5-22-004, 5-22-005, 5-22-006, 5-22-007, 5-22-008,5-22-009, 5-22-010 and 6-16, as well as others, were all deemed to beinferior or not acceptable (i.e., they did not include one or more (orall) of the beneficial characteristics that are described herein). Itwas also determined that hydrocortisone containing compositions and baseformulations that did not include the ingredient Finsolv TN exhibited aproblem with consistency over time as they deteriorated over time,thereby producing an undesirable gritty consistency. Finsolv TN is,thus, an important ingredient for inclusion in thehydrocortisone-containing and other active-agent containing compositionsand base formulations of the invention.

After many different topical hydrocortisone-containing formulations wereproduced, and after a very significant amount of experimentation andtesting of the same on human beings, it was determined that the topicalhydrocortisone-containing composition, and related base compositions,that include the particular ingredients that are described herein, andthe particular percent weights thereof have the very beneficial andadvantageous characteristics that are described herein.

EXAMPLE 2 Preparation of a Hydrocortisone Composition (not IncludingFlavoring) Initial Formulation

A batch of the same formulation that is described in Example 1 wasprepared in the same manner as is described in Example 1, with theexception that this batch did not include any flavoring. To compensatefor the absence of the 0.5 weight percent flavoring in this batch,additional castor oil was employed, bringing the total weight percent ofcastor oil up to 12 weight percent. This batch of the formulation wasdesignated as batch LTC#6-47 AH, and contained the components, andweight percents thereof, that are set forth below.

Ingredient Weight Percent Hydrocortisone 1.0 FANCOL VB 11.0 NatunolaCastor 1023 18.0 Finsolv TN 11.0 Bees Wax 20.0 Castor Oil 12.0 StearylAlcohol 20.0 Cocoa Butter 7.0 Flavoring (Vanilla) 0.0 TOTAL 100

EXAMPLE 3 Preparation of a Base Composition (not Including Flavoring orHydrocortisone) Initial Formulation

A batch of the same formulation that is described in Example 1 wasprepared in the same manner as is described in Example 1, with theexception that this batch did not include any flavoring or anyhydrocortisone. To compensate for the absence of the 0.5 weight percentflavoring and the 1.0 weight percent hydrocortisone in this batch,additional castor oil was employed, bringing the total weight percent ofcastor oil up to 13%. This batch of the formulation was designated asbatch LTC#6-47 A, and contained the components, and weight percentsthereof, that are set forth below.

Ingredient Weight Percent Hydrocortisone 0.0 FANCOL VB 11.0 NatunolaCastor 1023 18.0 Finsolv TN 11.0 Bees Wax 20.0 Castor Oil 13.0 StearylAlcohol 20.0 Cocoa Butter 7.0 Flavoring (Vanilla) 0.0 TOTAL 100

EXAMPLE 4 Testing of Hydrocortisone Composition Prepared in Example 1 onForearm, Wrist and Face of a Sixteen-Year-Old Male Patient Having Eczema

In the three topical skin treatment experiments that are describedbelow, a hydrocortisone formulation prepared as described in Example 1in a form of a large solid stick was applied to various areas of theskin of a sixteen-year-old male patient at varying application rates (ofabout 0.5 ml/application), as is described below, using a roll-upapplicator, as is shown in FIG. 1. These experiments were conducted byJoel Schlessinger, M.D., FAAD, FAACS, a board certified dermatologistand cosmetic surgeon.

In a first experiment, the composition was applied to the left forearmof the male patient, who had eczema on this forearm. FIGS. 2 and 3 arephotographs showing the left forearm of the patient (with eczema) as theforearm existed prior to receiving any type of treatment for the eczema.FIGS. 2 and 3 show the forearm having two plaques (elevated, solid,superficial lesions greater than 0.5 cm in diameter) present in the skinof the forearm. FIG. 5 is a photograph showing the same forearm that isshown in FIGS. 2 and 3, but as the forearm existed after being treatedonly with the hydrocortisone-containing composition of the invention,with twenty applications of the composition being applied to the forearmspaced equally apart over a period of seven days. FIG. 5 shows that thetwo eczema plaques that are present on the forearm shown in FIGS. 2 and3 completely disappeared after such treatment (i.e., the skin on theforearm was fully healed).

In a second experiment, the composition was applied to the left wrist ofthe same male patient, who had eczema on this wrist. FIG. 4 is aphotograph showing the left wrist of the patient (with eczema) as thewrist existed prior to receiving any type of treatment for the eczema.FIG. 5 is a photograph showing the same wrist that is shown in FIG. 4,but as the wrist existed after being treated only with thehydrocortisone-containing composition of the invention, with thirtyapplications of the composition being applied to the wrist spacedequally apart over a period of seven days. FIG. 5 shows that the eczemathat is present on the wrist in FIG. 4 completely disappeared after suchtreatment (i.e., the skin on the wrist was fully healed).

In a third experiment, the composition was applied to the face of thesame male patient, who had very dry lips, as well as eczema on the chin.FIG. 6 is a photograph showing the full face of the patient (with drylips and eczema on the chin) as the face existed prior to receiving anytype of treatment for the dry lips and eczema on the chin. FIG. 7 is aphotograph showing the chin area (with eczema) of the same face that isshown in FIG. 6 (i.e., a view that is closer up). FIG. 8 is a photographshowing the same face that is shown in FIG. 6 (including the same chinthat is shown in FIG. 7), but as the face (and chin) existed after beingtreated only with the hydrocortisone-containing composition of theinvention, with ten applications of the composition being applied to theface (including the lips and chin) spaced equally apart over a period ofseven days. FIG. 8 shows that the eczema on the chin in FIGS. 6 and 7completely disappeared (i.e., the skin on the chin was fully healed),and that the lips no longer were dry.

EXAMPLE 5 Testing of Hydrocortisone Composition Prepared in Example 1 onVarious Body Parts (Face, Cheeks, Chin, Lips, Fingers, Hands or Arms) ofEleven Other Patients Having Different Skin Disorders (Eczema, Cuts,Cracks, Peeling, Rashes, Irritation or Excessive Dryness)

In the topical skin treatment testing experiments that are describedbelow, a hydrocortisone formulation of the invention, prepared as isdescribed in Example 1, and in a form of a solid stick, was applied tovarious areas of the skin of eleven other human beings (patients) invarying quantities and at varying application rates, as is describedbelow, using a roll-up applicator, as is shown in FIG. 1. Detailedpatient feedback was subsequently provided to Joel Schlessinger, M.D.,FAAD, FAACS, a board certified dermatologist and cosmetic surgeon, whooversaw each of these experiments, and is described below.

The test subjects used for these studies were both male and femalepatients ranging from sixteen to seventy-eight years of age.

A control formulation was also employed in some of these studies. Thecontrol product was a formulation described in U.S. Pat. No. 6,228,351in most cases or an “over-the-counter” (non-prescription) lip balm ormedication that was prescription in nature (i.e., prescribed by amedical doctor).

Initial applications of the hydrocortisone formation, and of the controlformulation, topically to the skin of the test subjects, andinstructions for subsequent applications, were supervised by JoelSchlessinger, M.D., FAAD, FAACS.

A variety of application procedures were employed with respect to numberof applications of a test material and duration of applications in anattempt to reflect actual real world usage of these types of products,as well as to determine the extent to which observed results were afunction of duration and/or frequency of use. The application protocols(frequency and duration of use) varied as is discussed below. Each testsubject applied the hydrocortisone formulation, and separately thecontrol, to the areas of his or her lips or body that are describedbelow.

-   Patient Designated “TS,” Age 17, Male: Tested the formulation on his    lips, and liked the formulation, stating that it helped his lips to    heal. The composition was applied over a two-month period and    approximately five times per day.-   Patient Designated “KS.” Age 60. Female: Tested the formulation on    an eczematous area on her cheek, and liked the formulation, stating    that it healed the eczematous area on her cheek. The composition was    applied over a four-month period and two to three times daily.-   Patient Designated “LLH,” Female, Age 28: Tested the formulation on    her fingers and subsequently stated, “While it is a bit waxy in    feeling, it was a rather clean appearance while doing magic for my    condition on fingers.” The composition was applied over a two-month    period and two times daily.-   Patient Designated “MW,” Male, Age 22: Tested the formulation on his    lips for excessive dryness and subsequently stated, “I have been    using the lip balm and it seems to be working.” The composition was    applied over a three-month period and four times daily on average.-   Patient Designated “JB,” Male, Age 25: Tested the formulation on her    face for facial dryness and subsequently stated, “I have been using    it. It works very well.” The composition was applied over a    three-month period and twice daily.-   Patient Designated “EC,” Female, Age 78: Tested the formulation on    her lips for irritation and subsequently stated, “No irritation of    lips now.” The composition was applied over a six-month period and    six times daily.-   Patient Designated “DS,” Male, Age 16: Tested the formulation on his    fingers, hands, cheeks, chin, lips and arms in connection with    rashes and subsequently stated, “Worked wonderfully on my fingers,    hands, cheeks, chin, lips and arms to clear up rashes.” The    composition was applied over an eight-month period and approximately    four times daily for the lips and chin and three times daily for the    body and hands.-   Patient Designated “JHS,” Female, Age 76: Tested the formulation on    her fingers in connection with dry skin and cuts and subsequently    stated, “Liked the taste, and it was especially helpful for my dry    skin on the fingers and cuts.” The composition was applied over a    four-month period twice daily for the lips and fingers.-   Patient Designated “JS,” Male, Age 50: Tested the formulation on his    fingers in connection with dry skin and subsequently stated, “This    worked very nicely for me and helped my fingers when they were dry.”    The composition was applied over a nine-month period twice daily.-   Patient Designated “SH,” Female, Age 35: Tested the formulation on    her dry lips and subsequently stated, “I was struggling with my lips    becoming so dry. I told you about my concerns, dry, peeling, and my    bottom lip would crack in the middle, it was very painful. You had    me test your trial lip balm, and I absolutely loved it, and still    love it. I would put it on at night for bedtime, and after two    applications my lips were soft and perfect.” The composition was    applied over a five-month period at approximately twice daily.-   Patient Designated “RMS,” Female, Age 26: Tested the formulation on    her dry hands and subsequently stated, “It worked really well. I was    having pretty significant cracking due to the dry air and repeated    hand washing. It was thick and protective and helped to heal the    areas faster than any moisturizers I had tried. It was nice also to    just put it on the trouble areas and not have a thick product over    my entire hands.” The composition was applied over a four-month    period, using it three times daily on the areas.

EXAMPLE 6 Preparation of Another Hydrocortisone Composition (IncludingVanilla Flavoring) Improved Formulation—OTC

A batch of a preferred OTC vanilla-flavored hydrocortisone-containingtopical skin formulation of the present invention was prepared in themanner described below. The composition contained the components, andweight percents thereof, that are set forth below.

Ingredient Weight Percent Hydrocortisone 1.00 FANCOL VB 11.00 NatunolaCastor 1023 10.00 FINSOLV TN 15.00 Bees Wax 11.00 Castor Oil 24.50Stearyl Alcohol 20.00 Cocoa Butter 7.00 Vanilla Flavoring 0.50 TOTAL 100

60.88 pounds of castor oil were added to a standard stainless steel drumincluding a mixer and heated using Heating Bands (Expo Engineered Inc.,Cicero, Ill.) to a temperature ranging from about 75° C. to about 85°C., while stirring it continuously using the mixer.

27.50 pounds of FANCOL VB were added to the castor oil in the drum, andmixed with the castor oil until it was completely dissolved therein,which took about 30 minutes, while maintaining a temperature rangingfrom about 75° C. to about 85° C.

27.50 pounds of bees wax were then added to the above mixture of castoroil and FANCOL VB in the drum while a temperature ranging from about 75°C. to about 85° C. was maintained. Mixing of the ingredients wascontinued for about 30 minutes, which was sufficient to completelydissolve the bees wax therein.

50.00 pounds of stearyl alcohol were then added to the above mixture inthe drum while a temperature ranging from about 75° C. to about 85° C.was maintained. Mixing was continued for a period of about 30 minutes,which was sufficient to completely dissolve the stearyl alcohol therein.

17.50 pounds of cocoa butter were then added to the above mixture in thedrum while a temperature ranging from about 75° C. to about 85° C. wasmaintained. Mixing was continued for about 30 minutes, which wassufficient to completely dissolve the cocoa butter therein.

37.50 pounds of FINSOLV TN were then added to the above mixture in thedrum while a temperature ranging from about 75° C. to about 85° C. wasmaintained. Mixing was continued for a period of about 30 minutes, whichwas sufficient to completely dissolve the FINS OLV TN therein.

25.00 pounds of Natunola 1023 were added to the above mixture in thedrum while a temperature ranging from about 75° C. to about 85° C. wasmaintained. Mixing of the ingredients was then continued for about 60minutes.

The above mixture was mixed for an additional 30-60 minutes, which wassufficient to have any remaining particles present therein to becompletely dissolved in the mixture, while a temperature ranging fromabout 75° C. to about 85° C. was maintained.

2.88 pounds of hydrocortisone were then added to the above mixture andmixed until it dissolved therein, which took about 30 minutes, whilemaintaining the temperature of the mixture ranging from about 75° C. toabout 85° C.

The resulting mixture was then permitted to cool naturally to atemperature ranging from about 70° C. to about 80° C.

1.25 pounds of vanilla flavoring were added to the above mixture in thedrum while a temperature ranging from about 70° C. to about 80° C. wasmaintained. Mixing of the ingredients was then continued for about 15-20minutes.

The resulting mixture was liquid in nature, light yellow in color, andhad a general appearance of a thin milky liquid.

Once the sample (mixture) was found to be acceptable (i.e., to possessthe above characteristics), the entire batch of the composition wastransferred to the filling area, where it was manually poured into theindividual plastic containers to form the following shapes and sizes:

-   -   (i) a 0.15 fluid ounce stick-shaped roll-up skin balm measuring        about 6.0 cm in length and about 1.5 cm in diameter (a suitable        size for a lip balm);    -   (ii) a 0.50 fluid ounce stick-shaped roll-up skin balm measuring        about 7.6 cm in length and about 2.0 cm in diameter (a suitable        size for a body balm); and    -   (iii) a 0.25 fluid ounce jar-shaped skin balm measuring about        3.0 cm in length and about 3.3 cm in diameter (a suitable size        for a face balm).

After the compositions settled and hardened in the containers, whichgenerally took about 60 minutes, a container cap made of plasticmaterial was placed onto the open end of each container and then a labelincluding a batch code and expiration date was placed onto either thelabel or the container.

A sample of the finished product was then analyzed using HighPerformance Liquid Chromatography (HPLC) or Gas Chromatography (GC) todetect the percentage of hydrocortisone for characteristics of onepercent hydrocortisone. Also, a sample of the finished product wastested to confirm its compliance with an established U.S. specificationfor microbiological quality using the known USP Microbial Limits Test,which is described in Chapter 61 and 62 of the U.S. Pharmacopeia (USP)for Microbial Limits, which is hereby incorporated herein by referencein its entirety.

The topical skin formulation that was prepared in this example may becontained in stick, jar, pot and/or other suitable or desirablecontainers (of a wide variety of different shapes, sizes and materials)including the above, or other suitable or desirable, quantities thereof.

EXAMPLE 7 Preparation of another Hydrocortisone Composition (NotIncluding any Flavoring) Improved Formulation—OTC

A batch of another preferred OTC hydrocortisone skin formulation of thepresent invention in the form of a roll-up balm was prepared in themanner described in Example 6, and designated as batch LTC#6-47 AH. Thiscomposition differed from the composition described in Example 6 in thatit did not include any flavoring. The composition contained thecomponents, and weight percents thereof, that are set forth in Example6, with the exceptions that no flavoring component was included, and anadditional 0.5 weight percent of Castor Oil was included (in place ofthe 0.5 weight percent of flavoring), as is shown below.

Ingredient Weight Percent Hydrocortisone 1.00 FANCOL VB 11.00 NatunolaCastor 1023 10.00 FINSOLV TN 15.00 Bees Wax 11.00 Castor Oil 25.00Stearyl Alcohol 20.00 Cocoa Butter 7.00 TOTAL 100

62.13 pounds of castor oil were added to a standard stainless steel drumincluding a mixer and heated using Heating Bands to a temperatureranging from about 75° C. to about 85° C., while stirring itcontinuously using the mixer.

27.50 pounds of FANCOL VB were added to the castor oil in the drum, andmixed with the castor oil until it was completely dissolved therein,which took about 30 minutes, while maintaining a temperature rangingfrom about 75° C. to about 85° C.

27.50 pounds of bees wax were then added to the above mixture of castoroil and FANCOL VB in the drum while a temperature ranging from about 75°C. to about 85° C. was maintained. Mixing of the ingredients wascontinued for about 30 minutes, which was sufficient to completelydissolve the bees wax therein.

50.00 pounds of stearyl alcohol were then added to the above mixture inthe drum while a temperature ranging from about 75° C. to about 85° C.was maintained. Mixing was continued for a period of about 30 minutes,which was sufficient to completely dissolve the stearyl alcohol therein.

17.50 pounds of cocoa butter were then added to the above mixture in thedrum while a temperature ranging from about 75° C. to about 85° C. wasmaintained. Mixing was continued for about 30 minutes, which wassufficient to completely dissolve the cocoa butter therein.

37.50 pounds of FINSOLV TN were then added to the above mixture in thedrum while a temperature ranging from about 75° C. to about 85° C. wasmaintained. Mixing was continued for a period of about 30 minutes, whichwas sufficient to completely dissolve the FINSOLV TN therein.

25.00 pounds of Natunola 1023 were added to the above mixture in thedrum while a temperature ranging from about 75° C. to about 85° C. wasmaintained. Mixing of the ingredients was then continued for about 60minutes.

The above mixture was mixed for an additional 30-60 minutes, which wassufficient to have any remaining particles present therein to becompletely dissolved in the mixture, while a temperature ranging fromabout 75° C. to about 85° C. was maintained.

2.88 pounds of hydrocortisone were then added to the above mixture andmixed until it dissolved therein, which took about 30 minutes, whilemaintaining the temperature of the mixture ranging from about 75° C. toabout 85° C. The resulting mixture was liquid in nature, light yellow incolor, and had a general appearance of a thin milky liquid.

Once the sample (mixture) was found to be acceptable (i.e., to possessthe above characteristics), the entire batch of the composition wastransferred to the filling area, where it was manually poured into theindividual plastic containers to form the following shapes and sizes:

-   -   (i) a 0.15 fluid ounce stick-shaped roll-up skin balm measuring        about 6.0 cm in length and about 1.5 cm in diameter (a suitable        size for a lip balm);    -   (ii) a 0.50 fluid ounce stick-shaped roll-up skin balm measuring        about 7.6 cm in length and about 2.0 cm in diameter (a suitable        size for a body balm); and    -   (iii) a 0.25 fluid ounce jar-shaped skin balm measuring about        3.0 cm in length and about 3.3 cm in diameter (a suitable size        for a face balm).

After the compositions settled and hardened in the containers, whichgenerally took about 60 minutes, a container cap made of plasticmaterial was placed onto the open end of each container and then a labelincluding a batch code and expiration date was placed onto either thelabel or the container.

A sample of the finished product was then analyzed using HighPerformance Liquid Chromatography (HPLC) or Gas Chromatography (GC) todetect the percentage of hydrocortisone for characteristics of onepercent hydrocortisone. Also, a sample of the finished product wastested to confirm its compliance with an established U.S. specificationfor microbiological quality using the known USP Microbial Limits Test.

The topical skin formulation that was prepared in this example may becontained in stick, jar, pot and/or other suitable or desirablecontainers (of a wide variety of different shapes, sizes and materials)including the above, or other suitable or desirable, quantities thereof.

EXAMPLE 8 Preparation of Another Base Composition (not IncludingHydrocortisone, but Including Vanilla Flavoring) ImprovedFormulation—Non-OTC

A batch of a preferred non-OTC, vanilla-flavored, topical basecomposition of the present invention (not including hydrocortisone orany other active agent) was prepared in the manner described below. Thebase composition contained the components, and weight percents thereof,that are set forth below.

Ingredient Weight Percent FANCOL VB 11.00 Natunola Castor 1023 10.00FINSOLV TN 15.00 Bees Wax 11.00 Castor Oil 25.50 Stearyl Alcohol 20.00Cocoa Butter 7.00 Vanilla Flavoring 0.50 TOTAL 100

63.75 pounds of castor oil were added to a standard stainless steel drumincluding a mixer and heated using Heating Bands to a temperatureranging from about 75° C. to about 85° C., while stirring itcontinuously using the mixer.

27.50 pounds of FANCOL VB were added to the castor oil in the drum, andmixed with the castor oil until it was completely dissolved therein,which took about 30 minutes, while maintaining a temperature rangingfrom about 75° C. to about 85° C.

27.50 pounds of bees wax were then added to the above mixture of castoroil and FANCOL VB in the drum while a temperature ranging from about 75°C. to about 85° C. was maintained. Mixing of the ingredients wascontinued for about 30 minutes, which was sufficient to completelydissolve the bees wax therein.

50.00 pounds of stearyl alcohol were then added to the above mixture inthe drum while a temperature ranging from about 75° C. to about 85° C.was maintained. Mixing was continued for a period of about 30 minutes,which was sufficient to completely dissolve the stearyl alcohol therein.

17.50 pounds of cocoa butter were then added to the above mixture in thedrum while a temperature ranging from about 75° C. to about 85° C. wasmaintained. Mixing was continued for about 30 minutes, which wassufficient to completely dissolve the cocoa butter therein.

37.50 pounds of FINS OLV TN were then added to the above mixture in thedrum while a temperature ranging from about 75° C. to about 85° C. wasmaintained. Mixing was continued for a period of about 30 minutes, whichwas sufficient to completely dissolve the FINSOLV TN therein.

25.00 pounds of Natunola 1023 were added to the above mixture in thedrum while a temperature ranging from about 75° C. to about 85° C. wasmaintained. Mixing of the ingredients was then continued for about 60minutes.

The above mixture was mixed for an additional 30-60 minutes, which wassufficient to have any remaining particles present therein to becompletely dissolved in the mixture, while a temperature ranging fromabout 75° C. to about 85° C. was maintained.

The resulting mixture was then permitted to cool naturally to atemperature ranging from about 70° C. to about 80° C.

1.25 pounds of vanilla flavoring were added to the above mixture in thedrum while a temperature ranging from about 70° C. to about 80° C. wasmaintained. Mixing of the ingredients was then continued for about 15-20minutes.

The resulting mixture was liquid in nature, light yellow in color, andhad a general appearance of a thin milky liquid.

Once the sample (mixture) was found to be acceptable (i.e., to possessthe above characteristics), the entire batch of the composition wastransferred to the filling area, where it was manually poured into theindividual plastic containers to form the following shapes and sizes:

-   -   (i) a 0.15 fluid ounce stick-shaped roll-up skin balm measuring        about 6.0 cm in length and about 1.5 cm in diameter (a suitable        size for a lip balm);    -   (ii) a 0.50 fluid ounce stick-shaped roll-up skin balm measuring        about 7.6 cm in length and about 2.0 cm in diameter (a suitable        size for a body balm); and    -   (iii) a 0.25 fluid ounce jar-shaped skin balm measuring about        3.0 cm in length and about 3.3 cm in diameter (a suitable size        for a face balm).

After the compositions settled and hardened in the containers, whichgenerally took about 60 minutes, a container cap made of plasticmaterial was placed onto the open end of each container and then a labelincluding a batch code and expiration date was placed onto either thelabel or the container.

A sample of the finished product was then analyzed using HighPerformance Liquid Chromatography (HPLC) or Gas Chromatography (GC), andtested to confirm its compliance with an established U.S. specificationfor microbiological quality using the known USP Microbial Limits Test.

The base composition that was prepared in this example may be containedin stick, jar, pot and/or other suitable or desirable containers (of awide variety of different shapes, sizes and materials) including theabove, or other suitable or desirable, quantities thereof.

EXAMPLE 9 Preparation of Another Base Composition (not IncludingHydrocortisone or any Flavoring) Improved Formulation—Non-OTC

A batch of a preferred non-OTC, unflavored, topical base composition ofthe present invention (not including hydrocortisone or any other activeagent) was prepared in the manner described below. The base compositioncontained the components, and weight percents thereof, that are setforth below.

Ingredient Weight Percent FANCOL VB 11.00 Natunola Castor 1023 10.00FINSOLV TN 15.00 Bees Wax 11.00 Castor Oil 26.00 Stearyl Alcohol 20.00Cocoa Butter 7.00 TOTAL 100

65.00 pounds of castor oil were added to a standard stainless steel drumincluding a mixer and heated using Heating Bands to a temperatureranging from about 75° C. to about 85° C., while stirring itcontinuously using the mixer.

27.50 pounds of FANCOL VB were added to the castor oil in the drum, andmixed with the castor oil until it was completely dissolved therein,which took about 30 minutes, while maintaining a temperature rangingfrom about 75° C. to about 85° C.

27.50 pounds of bees wax were then added to the above mixture of castoroil and FANCOL VB in the drum while a temperature ranging from about 75°C. to about 85° C. was maintained. Mixing of the ingredients wascontinued for about 30 minutes, which was sufficient to completelydissolve the bees wax therein.

50.00 pounds of stearyl alcohol were then added to the above mixture inthe drum while a temperature ranging from about 75° C. to about 85° C.was maintained. Mixing was continued for a period of about 30 minutes,which was sufficient to completely dissolve the stearyl alcohol therein.

17.50 pounds of cocoa butter were then added to the above mixture in thedrum while a temperature ranging from about 75° C. to about 85° C. wasmaintained. Mixing was continued for about 30 minutes, which wassufficient to completely dissolve the cocoa butter therein.

37.50 pounds of FINS OLV TN were then added to the above mixture in thedrum while a temperature ranging from about 75° C. to about 85° C. wasmaintained. Mixing was continued for a period of about 30 minutes, whichwas sufficient to completely dissolve the FINSOLV TN therein.

25.00 pounds of Natunola 1023 were added to the above mixture in thedrum while a temperature ranging from about 75° C. to about 85° C. wasmaintained. Mixing of the ingredients was then continued for about 60minutes.

The above mixture was mixed for an additional 30-60 minutes, which wassufficient to have any remaining particles present therein to becompletely dissolved in the mixture, while a temperature ranging fromabout 75° C. to about 85° C. was maintained.

The resulting mixture was liquid in nature, light yellow in color, andhad a general appearance of a thin milky liquid.

Once the sample (mixture) was found to be acceptable (i.e., to possessthe above characteristics), the entire batch of the composition wastransferred to the filling area, where it was manually poured into theindividual plastic containers to form the following shapes and sizes:

-   -   (i) a 0.15 fluid ounce stick-shaped roll-up skin balm measuring        about 6.0 cm in length and about 1.5 cm in diameter (a suitable        size for a lip balm);    -   (ii) a 0.50 fluid ounce stick-shaped roll-up skin balm measuring        about 7.6 cm in length and about 2.0 cm in diameter (a suitable        size for a body balm); and    -   (iii) a 0.25 fluid ounce jar-shaped skin balm measuring about        3.0 cm in length and about 3.3 cm in diameter (a suitable size        for a face balm).

After the compositions settled and hardened in the containers, whichgenerally took about 60 minutes, a container cap made of plasticmaterial was placed onto the open end of each container and then a labelincluding a batch code and expiration date was placed onto either thelabel or the container.

A sample of the finished product was then analyzed using HighPerformance Liquid Chromatography (HPLC) or Gas Chromatography (GC), andtested to confirm its compliance with an established U.S. specificationfor microbiological quality using the known USP Microbial Limits Test.

The base composition that was prepared in this example may be containedin stick, jar, pot and/or other suitable or desirable containers (of awide variety of different shapes, sizes and materials) including theabove, or other suitable or desirable, quantities thereof.

EXAMPLE 10 Testing of Hydrocortisone Composition Prepared in Example 6on Left and Right Hands of Fifty-Year-Old Female Patient HavingPsoriasis

In the topical skin treatment experiments that are described below, ahydrocortisone formulation prepared as described in Example 6 in a formof a large solid stick (including approximately 14.78 ml of theformulation), was applied to the left and right hands (both sides ofeach hand) of a fifty-year-old female patient having psoriasis, whoseinitials are PT, at an application rate of about 100 applications ofabout 0.5 ml/application of the composition being equally spaced apartover a period of 30 days (i.e., about 3-4 applications per day). Theseexperiments were conducted by Joel Schlessinger, M.D., FAAD, FAACS, aboard certified dermatologist and cosmetic surgeon.

Long prior to these experiments, this same female patient had tried toimprove or eradicate the above-described skin disorders on her left andright hands using a wide variety of different known “over-the-counter”(non-prescription) and prescription (prescribed by a medical doctor)topical skin products, including balms, and those including one or moreactive agents, such as hydrocortisone. She tried numerous differentforms of topical compositions including hydrocortisone on her hands, aswell as other, more powerful forms of corticosteroids, oral medicationsand injectable medications. She, however, did not have success with anyof these topical compositions or medications (i.e., her skin disorderswere not significantly improved or eradicated by any of thesecompositions or medications), as can clearly be seen in each of the“before” photographs that are shown in FIGS. 9A, 10A, 11A, 12A, 13A and14A (photographs taken before the experiments described in this examplewere preformed).

FIG. 9A shows the dorsal aspect of the left hand as it was present priorto receiving any type of treatment with a composition of the inventionfor the dryness, cracks, and cuts appearing thereon, with an emphasis onthe thumb and the index finger. FIG. 9B shows the same dorsal aspectthat is shown in FIG. 9A, but as this hand existed after being treatedonly with the hydrocortisone-containing solid composition (in the mannerdescribed above). A comparison of the left hand that is shown in FIG. 9Awith the left hand that is shown in FIG. 9B shows that the dryness andcracks that are shown in FIG. 9A are significantly moisturized andreduced, and that the cuts that are shown in FIG. 9A have completelydisappeared (i.e., have a 100% improvement).

FIG. 10A shows the palmar aspect of the same left hand as it was presentprior to receiving any type of treatment with a composition of theinvention for the dryness, cracks, and cuts appearing thereon, with anemphasis on the thumb and the palm. FIG. 10B shows the same palm that isshown in FIG. 10A, but as the palm existed after being treated only withthe hydrocortisone-containing solid composition (in the manner describedabove). A comparison of the left hand that is shown in FIG. 10A with theleft hand that is shown in FIG. 10B shows that the dryness and cracksthat are shown in FIG. 10A are significantly moisturized and reduced,and that the cuts that are shown in FIG. 10A have completely disappeared(i.e., have a 100% improvement).

FIG. 11A shows the dorsal aspect of the right hand as it was presentprior to receiving any type of treatment with a composition of theinvention for the dryness, cracks, and cuts appearing thereon, with anemphasis on the thumb, index finger, and knuckles. FIG. 11B shows thesame dorsal aspect that is shown in FIG. 11A, but as the hand existedafter being treated only with the hydrocortisone-containing solidcomposition (in the manner described above). A comparison of the righthand that is shown in FIG. 11A with the right hand that is shown in FIG.11B shows that the dryness and cracks that are shown in FIG. 11A aresignificantly moisturized and reduced, and that the cuts that are shownin FIG. 11A have completely disappeared (i.e., have a 100% improvement).

FIG. 12A shows the palmar aspect of the right hand as it was presentprior to receiving any type of treatment with a composition of theinvention for the dryness, cracks, and cuts appearing thereon, with anemphasis on the palm, thumb, and index finger. FIG. 12B shows the samepalm that is shown in FIG. 12A, but as the palm existed after beingtreated only with the hydrocortisone-containing solid composition (inthe manner described above). A comparison of the right hand that isshown in FIG. 12A with the right hand that is shown in FIG. 12B showsthat the dryness and cracks that are shown in FIG. 12A are significantlymoisturized and reduced, and that the cuts that are shown in FIG. 12Ahave completely disappeared (i.e., have a 100% improvement).

FIG. 13A shows the same dorsal aspects of the same left and right hands,as they were present prior to receiving any type of treatment with acomposition of the invention for the dryness, cracks, and cuts appearingthereon, with an emphasis on the thumbs, index fingers, and knuckles ofboth hands. FIG. 13B shows the same left and right hands that are shownin FIG. 13A, but as the left and right hands existed after being treatedonly with the hydrocortisone-containing solid composition (in the mannerdescribed above). A comparison of the left and right hands that areshown in FIG. 13A with the left and right hands that are shown in FIG.13B shows that the dryness and cracks that are shown in FIG. 13A aresignificantly moisturized and reduced, and that the cuts that are shownin FIG. 13A have completely disappeared (i.e., have a 100% improvement).

FIG. 14A shows the same palmar aspects of the same left and right hands,as they were present prior to receiving any type of treatment with acomposition of the invention for the dryness, cracks, and cuts appearingthereon, with an emphasis on the palms, thumbs, and index fingers ofboth hands. FIG. 14B shows the same left and right hands that are shownin FIG. 14A, but as the left and right hands existed after being treatedonly with a hydrocortisone-containing solid composition of the invention(in the manner described above). A comparison of the left and righthands that are shown in FIG. 14A with the left and right hands that areshown in FIG. 14B shows that the dryness and cracks that are shown inFIG. 14A are significantly moisturized and reduced, and that the cutsthat are shown in FIG. 14A have completely disappeared (i.e., have a100% improvement).

The experiments that are described in this example show the verysignificant advantages and benefits of hydrocortisone-containing topicalcompositions of the present invention, which were very efficacious inhealing the above-described skin disorders, in comparison with otherknown hydrocortisone-containing topical compositions, which were notefficacious in healing the same skin disorders on the same hands of thesame patient.

EXAMPLE 11 Testing of Hydrocortisone Composition Prepared in Example 6on Face of Thirty-Five-Year-Old Female Patient Having SeborrheicDermatitis

In the topical skin treatment experiments that are described below, ahydrocortisone formulation prepared as described in Example 6, and in aform of a small solid stick having the smaller size shown in FIG. 1, wasapplied to the face of a thirty-five-year-old female patient havingseborrheic dermatitis, whose initials are SN, at an application rate of21 applications of about 0.1 ml/application of the composition beingequally spaced apart over a period of 7 days (i.e., 3 applications perday). These experiments were conducted by Joel Schlessinger, M.D., FAAD,FAACS, a board certified dermatologist and cosmetic surgeon.

FIG. 15A shows this patient's face as it was present prior to receivingany type of treatment for the erythema of the nasolabial folds appearingthereon. FIG. 15B shows the same face that is shown in FIG. 15A, but asthe face existed after being treated only with thehydrocortisone-containing solid composition (in the manner describedabove). A comparison of the face that is shown in FIG. 15A with the facethat is shown in FIG. 15B shows that the scaling and erythema that isshown in FIG. 15A was significantly reduced.

EXAMPLE 12 Testing of Hydrocortisone Composition Prepared in Example 6on Face of Forty-One-Year-Old Male Patient Having Seborrheic Dermatitis

In the topical skin treatment experiments that are described below, ahydrocortisone formulation prepared as described in Example 6, and in aform of a small solid stick having the smaller size shown in FIG. 1, wasapplied to the face of a forty-one-year-old male patient havingseborrheic dermatitis, whose initials are JT, at an application rate of21 applications of about 0.1 ml/application of the composition beingequally spaced apart over a period of 7 days (i.e., 3 applications perday). These experiments were conducted by Joel Schlessinger, M.D., FAAD,FAACS, a board certified dermatologist and cosmetic surgeon.

FIG. 16A shows this patient's face as it was present prior to receivingany type of treatment for the seborrheic dermatitis appearing thereon.FIG. 16B shows the same face that is shown in FIG. 16A, but as the faceexisted after being treated only with the hydrocortisone-containingsolid composition (in the manner described above). A comparison of theface that is shown in FIG. 16A with the face that is shown in FIG. 16Bshows that the seborrheic dermatitis, scaling and erythema that is shownin FIG. 16A was significantly reduced.

EXAMPLE 13 Testing of Hydrocortisone Composition Prepared in Example 6on Face of Seventeen-Year-Old Female Patient Having Eczema

In the topical skin treatment experiments that are described below, ahydrocortisone formulation prepared as described in Example 6, and in aform of a small solid stick having the smaller size shown in FIG. 1, wasapplied to the face of a 17-year-old female patient having eczema, whoseinitials are SR, at an application rate of 21 applications of about 0.1ml/application of the composition being equally spaced apart over aperiod of 7 days (i.e., 3 applications per day). These experiments wereconducted by Joel Schlessinger, M.D., FAAD, FAACS, a board certifieddermatologist and cosmetic surgeon.

FIG. 17A shows this patient's face as it was present prior to receivingany type of treatment for the eczema appearing thereon. FIG. 17B showsthe same face that is shown in FIG. 17A, but as the face existed afterbeing treated only with the hydrocortisone-containing solid composition(in the manner described above). A comparison of the face that is shownin FIG. 17A with the face that is shown in FIG. 17B shows that theeczema that is shown in FIG. 17A was significantly reduced (reduced byabout 80%).

EXAMPLE 14 Testing of Hydrocortisone Composition Prepared in Example 6on Hands of Fifty-Three-Year-Old Female Patient Having Eczema

In the topical skin treatment experiments that are described below, ahydrocortisone formulation prepared as described in Example 6, and in aform of a small solid stick having the smaller size shown in FIG. 1, wasapplied to the hands of a 53-year-old female patient with initials PRfor eczema that a steriod ointment was unable to completely clear.Specifically, 18 applications of about 0.1 ml/application of thecomposition were applied to each hand, the applications being equallyspaced apart over a period of 9 days (i.e., 2 applications per day perhand). These experiments were conducted by Joel Schlessinger, M.D.,FAAD, FAACS, a board certified dermatologist and cosmetic surgeon.

FIG. 18A shows this patient's left hand as it was present prior toreceiving any type of treatment for the eczema appearing thereon justbelow the base of the ring finger. FIG. 18B shows the same hand that isshown in FIG. 18A, but as the hand existed after being treated only withthe hydrocortisone-containing solid composition (in the manner describedabove). A comparison of the hand that is shown in FIG. 18A with the handthat is shown in FIG. 18B shows that the eczema that is shown in FIG.18A had completely cleared (i.e., a 100% improvement). Similarly, FIG.19A shows this patient's right hand as it was present prior to receivingany type of treatment for the eczema appearing thereon at the base ofthe fourth finger. FIG. 19B shows the same hand that is shown in FIG.19A, but as the hand existed after being treated only with thehydrocortisone-containing solid composition (in the manner describedabove). A comparison of the hand that is shown in FIG. 19A with the handthat is shown in FIG. 19B shows that the eczema that is shown in FIG.19A had completely cleared (i.e., a 100% improvement).

While the present invention has been described herein with specificity,and with reference to certain preferred embodiments thereof, those ofordinary skill in the art will recognize numerous variations,modifications and substitutions of that which has been described whichcan be made, and which are within the scope and spirit of the invention.It is intended that all of these modifications and variations be withinthe scope of the present invention as described and claimed herein, andthat the invention be limited only by the scope of the claims whichfollow, and that such claims be interpreted as broadly as is reasonable.

Throughout this document, various books, patents, patent applications,journal articles, web sites and other publications have been cited. Theentireties of each of these books, patents, patent applications, journalarticles, web sites and other publications are hereby incorporated byreference herein.

What is claimed is:
 1. A topical base composition in a solid orsemi-solid form for use as a carrier vehicle for one or a plurality ofactive agents, consisting of (i) Limnanthes Alba (Meadowfoam) Seed Oil,Butyrospermum Parkii (Shea Butter) Extract, (ii) Ricinus Communis(Castor) Seed Oil (and) Glycine Soja (Soybean) Germ Extract (and) ZeaMays (Corn) Starch (and) Silica, (iii) C₁₂₋₁₅ Alkyl Benzoate, and (iv)bees wax, each in amounts that are effective for collectively forming abase composition having an ability to function effectively as atopically-applied carrier vehicle for the active agents, wherein thebase composition is effective in promoting or causing a penetration ofthe active agents within one or more layers, tissues, or layers andtissues, of skin of a mammal that is damaged, injured, diseased or hasan inflammatory reaction or condition.
 2. A topical base composition ina solid or semi-solid form for use as a carrier vehicle for one or aplurality of active agents, consisting of (i) Limnanthes Alba(Meadowfoam) Seed Oil, Butyrospermum Parkii (Shea Butter) Extract, (ii)Ricinus Communis (Castor) Seed Oil (and) Glycine Soja (Soybean) GermExtract (and) Zea Mays (Corn) Starch (and) Silica, (iii) C₁₂₋₁₅ AlkylBenzoate, and (iv) bees wax, and one or a plurality of plant oils, plantseed oils, fatty alcohols or fats, or any combination thereof, each incombined amounts that are effective for collectively forming a basecomposition having an ability to function effectively as atopically-applied carrier vehicle for the active agents, wherein thebase composition is effective in promoting or causing a penetration ofthe active agents within one or more layers, tissues, or layers andtissues, of skin of a mammal that is damaged, injured, diseased or hasan inflammatory reaction or condition.
 3. A topical base composition ina solid or semi-solid form for use as a carrier vehicle for one or aplurality of active agents, consisting of (i) Limnanthes Alba(Meadowfoam) Seed Oil, Butyrospermum Parkii (Shea Butter) Extract, (ii)Ricinus Communis (Castor) Seed Oil (and) Glycine Soja (Soybean) GermExtract (and) Zea Mays (Corn) Starch (and) Silica, (iii) C₁₂₋₁₅ AlkylBenzoate, and (iv) bees wax, and one or a plurality of flavorings, andone or a plurality of plant oils, plant seed oils, fatty alcohols orfats, or any combination thereof, each in combined amounts that areeffective for collectively forming a base composition having an abilityto function effectively as a topically-applied carrier vehicle for theactive agents, wherein the base composition is effective in promoting orcausing a penetration of the active agents within one or more layers,tissues, or layers and tissues, of skin of a mammal that is damaged,injured, diseased or has an inflammatory reaction or condition, andwherein the base composition does not have a bitter taste or odor, hasno distinctive taste or odor or has a pleasant taste or odor.
 4. Atopical base composition in a solid or semi-solid form for use as acarrier vehicle for one or a plurality of active agents, comprising (i)11.00 weight percent Limnanthes Alba (Meadowfoam) Seed Oil,Butyrospermum Parkii (Shea Butter) Extract, (ii) 10.00 weight percentRicinus Communis (Castor) Seed Oil (and) Glycine Soja (Soybean) GermExtract (and) Zea Mays (Corn) Starch (and) Silica, (iii) 15.00 weightpercent C₁₂₋₁₅ Alkyl Benzoate, (iv) 11.00weight percent Bees Wax, (v)26.00 weight percent Castor Oil, (vi) 20.00 weight percent StearylAlcohol, (vii) 7.00 weight percent Cocoa Butter, and (viii) 0.00 weightpercent Flavoring (Vanilla), wherein the base composition has an abilityto function effectively as a topically-applied carrier vehicle for theactive agents, and wherein the base composition is effective inpromoting or causing a penetration of the active agents within one ormore layers, tissues, or layers and tissues, of skin of a mammal that isdamaged, injured, diseased or has an inflammatory reaction or condition.5. A topical base composition in a solid or semi-solid form for use as acarrier vehicle for one or a plurality of active agents, consisting of:(a) Limnanthes Alba (Meadowfoam) Seed Oil, Butyrospermum Parkii (SheaButter) Extract, wherein the Limnanthes Alba (Meadowfoam) Seed Oil,Butyrospermum Parkii (Shea Butter) Extract is present in the basecomposition in an amount ranging from about 6 to about 25 weightpercent; (b) Ricinus Communis (Castor) Seed Oil (and) Glycine Soja(Soybean) Germ Extract (and) Zea Mays (Corn) Starch (and) Silica,wherein the Ricinus Communis (Castor) Seed Oil (and) Glycine Soja(Soybean) Germ Extract (and) Zea Mays (Corn) Starch (and) Silica ispresent in the base composition in an amount ranging from about 5 toabout 39 weight percent; (c) C₁₂₋₁₅ Alkyl Benzoate, wherein the C₁₂₋₁₅Alkyl Benzoate is present in the base composition in an amount rangingfrom about 9 to about 25 weight percent; (d) bees wax, wherein the beeswax is present in the base composition in an amount ranging from about 6to about 43 weight percent; (e) optionally, one or a plurality of plantoils or plant seed oils, wherein the plant oils or plant seed oils arepresent in the base composition in a combined amount ranging from about0 to about 38.5 weight percent; (f) optionally, one or a plurality offatty alcohols, wherein the fatty alcohols are present in the basecomposition in a combined amount ranging from about 0 to about 25 weightpercent; (g) optionally, one or a plurality of fats, wherein the fatsare present in the base composition in a combined amount ranging fromabout 0 to about 12 weight percent; and (h) optionally, one or aplurality of flavorings, wherein the flavorings are present in the basecomposition in a combined amount ranging from about 0 to about 3.5weight percent; wherein the base composition has an ability to functioneffectively as a topically-applied carrier vehicle for the activeagents, and wherein the base composition is effective in promoting orcausing a penetration of the active agents within one or more layers,tissues, or layers and tissues, of skin of a mammal that is damaged,injured, diseased or has an inflammatory reaction or condition.
 6. Abase composition of claim 5, wherein the base composition includes oneor more flavorings.
 7. A topical base composition in a solid orsemi-solid form for use as a carrier vehicle for one or a plurality ofactive agents, consisting of: (a) Limnanthes Alba (Meadowfoam) Seed Oil,Butyrospermum Parkii (Shea Butter) Extract, wherein the Limnanthes Alba(Meadowfoam) Seed Oil, Butyrospermum Parkii (Shea Butter) Extract ispresent in the base composition in an amount ranging from about 6 toabout 25 weight percent; (b) Ricinus Communis (Castor) Seed Oil (and)Glycine Soja (Soybean) Germ Extract (and) Zea Mays (Corn) Starch (and)Silica, wherein the Ricinus Communis (Castor) Seed Oil (and) GlycineSoja (Soybean) Germ Extract (and) Zea Mays (Corn) Starch (and) Silica ispresent in the base composition in an amount ranging from about 5 toabout 39 weight percent; (c) C₁₂₋₁₅ Alkyl Benzoate, wherein the C₁₂₋₁₅Alkyl Benzoate is present in the base composition in an amount rangingfrom about 9 to about 25 weight percent; (d) bees wax, wherein the beeswax is present in the base composition in an amount ranging from about 6to about 43 weight percent; (e) one or more plant oils or plant seedoils, wherein the plant oils or plant seed oils are present in the basecomposition in a combined amount ranging from about 0.1 to about 38.5weight percent; (f) one or more fatty alcohols, wherein the fattyalcohols are present in the base composition in a combined amountranging from about 0.1 to about 25 weight percent; (g) one or more fats,wherein the fats are present in the base composition in a combinedamount ranging from about 0.1 to about 12 weight percent; and (h)optionally, one or more flavorings, wherein the flavorings are presentin the base composition in an amount ranging from about 0 to about 3.5weight percent; wherein the base composition has an ability to functioneffectively as a topically-applied carrier vehicle for the activeagents, and wherein the base composition is effective in promoting orcausing a penetration of the active agents within one or more layers,tissues, or layers and tissues, of skin of a mammal that is damaged,injured, diseased or has an inflammatory reaction or condition.
 8. Abase composition of claim 7, wherein the base composition includes oneor more flavorings.
 9. A topical base composition in a solid orsemi-solid form for use as a carrier vehicle for one or a plurality ofactive agents, consisting of: (a) Limnanthes Alba (Meadowfoam) Seed Oil,Butyrospermum Parkii (Shea Butter) Extract, wherein the Limnanthes Alba(Meadowfoam) Seed Oil, Butyrospermum Parkii (Shea Butter) Extract ispresent in the base composition in an amount ranging from about 6 toabout 16 weight percent; (b) Ricinus Communis (Castor) Seed Oil (and)Glycine Soja (Soybean) Germ Extract (and) Zea Mays (Corn) Starch (and)Silica, wherein the Ricinus Communis (Castor) Seed Oil (and) GlycineSoja (Soybean) Germ Extract (and) Zea Mays (Corn) Starch (and) Silica ispresent in the base composition in an amount ranging from about 5 toabout 15 weight percent; (c) C₁₂₋₁₅ Alkyl Benzoate, wherein the C₁₂₋₁₅Alkyl Benzoate is present in the base composition in an amount rangingfrom about 10 to about 20 weight percent; (d) bees wax, wherein the beeswax is present in the base composition in an amount ranging from about 6to about 16 weight percent; (e) one or more plant oils or plant seedoils, wherein the plant oils or plant seed oils are present in the basecomposition in a combined amount ranging from about 13 to about 38.5weight percent; (f) one or more fatty alcohols, wherein the fattyalcohols are present in the base composition in a combined amountranging from about 15 to about 25 weight percent; (g) one or more fats,wherein the fats are present in the base composition in a combinedamount ranging from about 2 to about 12 weight percent; and (h)optionally, one or more flavorings, wherein the flavorings are presentin the base composition in an amount ranging from about 0 to about 3.5weight percent; wherein the base composition has an ability to functioneffectively as a topically-applied carrier vehicle for the activeagents, and wherein the base composition is effective in promoting orcausing a penetration of the active agents within one or more layers,tissues, or layers and tissues, of skin of a mammal that is damaged,injured, diseased or has an inflammatory reaction or condition.
 10. Abase composition of claim 9, wherein the base composition includes oneor more flavorings.
 11. A topical base composition in a solid orsemi-solid form for use as a carrier vehicle for one or a plurality ofactive agents, consisting of: (a) Limnanthes Alba (Meadowfoam) Seed Oil,Butyrospermum Parkii (Shea Butter) Extract, wherein the Limnanthes Alba(Meadowfoam) Seed Oil, Butyrospermum Parkii (Shea Butter) Extract ispresent in the base composition in an amount ranging from about 10 toabout 12 weight percent; (b) Ricinus Communis (Castor) Seed Oil (and)Glycine Soja (Soybean) Germ Extract (and) Zea Mays (Corn) Starch (and)Silica, wherein the Ricinus Communis (Castor) Seed Oil (and) GlycineSoja (Soybean) Germ Extract (and) Zea Mays (Corn) Starch (and) Silica ispresent in the base composition in an amount ranging from about 9 toabout 11 weight percent; (c) C₁₂₋₁₅ Alkyl Benzoate, wherein the C₁₂₋₁₅Alkyl Benzoate is present in the base composition in an amount rangingfrom about 14 to about 16 weight percent; (d) bees wax, wherein the beeswax is present in the base composition in an amount ranging from about10 to about 12 weight percent; (e) one or more plant oils or plant seedoils, wherein the plant oils or plant seed oils are present in the basecomposition in a combined amount ranging from about 24.5 to about 27weight percent; (f) one or more fatty alcohols, wherein the fattyalcohols are present in the base composition in a combined amountranging from about 19 to about 21 weight percent; (g) one or more fats,wherein the fats are present in the base composition in a combinedamount ranging from about 6 to about 8 weight percent; and (h)optionally, one or more flavorings, wherein the flavorings are presentin the base composition in an amount ranging from about 0 to about 3.5weight percent; wherein the base composition has an ability to functioneffectively as a topically-applied carrier vehicle for the activeagents, and wherein the base composition is effective in promoting orcausing a penetration of the active agents within one or more layers,tissues, or layers and tissues, of skin of a mammal that is damaged,injured, diseased or has an inflammatory reaction or condition.
 12. Abase composition of claim 11, wherein the base composition includes oneor more flavorings.
 13. A base composition of claim 5, wherein the plantoil or plant seed oil is castor oil, the fatty alcohol is stearylalcohol or the fat is cocoa butter, or any combination thereof.
 14. Abase composition of claim 6, wherein the plant oil or plant seed oil iscastor oil, the fatty alcohol is stearyl alcohol or the fat is cocoabutter, or any combination thereof.
 15. A base composition of claim 7,wherein the plant oil or plant seed oil is castor oil, the fatty alcoholis stearyl alcohol or the fat is cocoa butter, or any combinationthereof.
 16. A base composition of claim 8, wherein the plant oil orplant seed oil is castor oil, the fatty alcohol is stearyl alcohol orthe fat is cocoa butter, or any combination thereof.
 17. A basecomposition of claim 9, wherein the plant oil or plant seed oil iscastor oil, the fatty alcohol is stearyl alcohol or the fat is cocoabutter, or any combination thereof.
 18. A base composition of claim 10,wherein the plant oil or plant seed oil is castor oil, the fatty alcoholis stearyl alcohol or the fat is cocoa butter, or any combinationthereof.
 19. A base composition of claim 11, wherein the plant oil orplant seed oil is castor oil, the fatty alcohol is stearyl alcohol orthe fat is cocoa butter, or any combination thereof.
 20. A basecomposition of claim 12, wherein the plant oil or plant seed oil iscastor oil, the fatty alcohol is stearyl alcohol or the fat is cocoabutter, or any combination thereof.
 21. A composition in a solid orsemi-solid form for topical application to the skin of a mammal forrepairing, improving or fully healing a skin disorder, disease, adversecondition, or other condition that requires, or could benefit from,improvement, or for causing the mammal's skin to experience a reductionin pain, soreness or itchiness, or a combination thereof, comprising (i)1.0 weight percent Hydrocortisone, (ii) 11.00 weight percent LimnanthesAlba (Meadowfoam) Seed Oil, Butyrospermum Parkii (Shea Butter) Extract,(iii) 10.00 weight percent Ricinus Communis (Castor) Seed Oil (and)Glycine Soja (Soybean) Germ Extract (and) Zea Mays (Corn) Starch (and)Silica, (iv) 15.00 weight percent C₁₂₋₁₅ Alkyl Benzoate, (v) 11.00weight percent Bees Wax; (vi) 24.50 weight percent Castor Oil, (vii)20.00 weight percent Stearyl Alcohol, (viii) 7.00 weight percent CocoaButter, and (ix) 0.50 weight percent Flavoring (Vanilla), wherein thecomposition is effective in repairing, improving or fully healing skinof the mammal that is damaged, injured, diseased, has an inflammatoryreaction or condition, or requires, or could benefit from, improvement,or in causing the mammal's skin to experience a reduction in pain,soreness or itchiness, or a combination thereof, and wherein thecomposition has an ability to act within one or more layers, tissues, orlayers and tissues, of the skin of the mammal that is damaged, injured,diseased, has an inflammatory reaction or condition, or requires, orcould benefit from, improvement.
 22. A composition in a solid orsemi-solid form for topical application to the skin of a mammal forrepairing, improving or fully healing a skin disorder, disease, adversecondition, or other condition that requires, or could benefit from,improvement, or for causing the mammal's skin to experience a reductionin pain, soreness or itchiness, or a combination thereof, consisting of:(a) one or a plurality of active agents, wherein the active agents arepresent in the composition in a combined amount ranging from about 0.1to about 5 weight percent; (b) Limnanthes Alba (Meadowfoam) Seed Oil,Butyrospermum Parkii (Shea Butter) Extract, wherein the Limnanthes Alba(Meadowfoam) Seed Oil, Butyrospermum Parkii (Shea Butter) Extract ispresent in the composition in an amount ranging from about 6 to about 25weight percent; (c) Ricinus Communis (Castor) Seed Oil (and) GlycineSoja (Soybean) Germ Extract (and) Zea Mays (Corn) Starch (and) Silica,wherein the Ricinus Communis (Castor) Seed Oil (and) Glycine Soja(Soybean) Germ Extract (and) Zea Mays (Corn) Starch (and) Silica ispresent in the composition in an amount ranging from about 5 to about 39weight percent; (d) C₁₂₋₁₅ Alkyl Benzoate, wherein the C₁₂₋₁₅ AlkylBenzoate is present in the composition in an amount ranging from about 9to about 25 weight percent; (e) bees wax, wherein the bees wax ispresent in the composition in an amount ranging from about 6 to about 43weight percent; (f) optionally, one or a plurality of plant oils orplant seed oils, wherein the plant oils or plant seed oils are presentin the composition in a combined amount ranging from about 0 to about37.5 weight percent; (g) optionally, one or a plurality of fattyalcohols, wherein the fatty alcohols are present in the composition in acombined amount ranging from about 0 to about 25 weight percent; (h)optionally, one or a plurality of fats, wherein the fats are present inthe composition in a combined amount ranging from about 0 to about 12weight percent; and (i) optionally, one or a plurality of flavorings,wherein the flavorings are present in the composition in a combinedamount ranging from about 0 to about 3.5 weight percent, wherein thecomposition is effective in repairing, improving or fully healing skinof the mammal that is damaged, injured, diseased, has an inflammatoryreaction or condition, or requires, or could benefit from, improvement,or in causing the mammal's skin to experience a reduction in pain,soreness or itchiness, or a combination thereof, and wherein thecomposition has an ability to act within one or more layers, tissues, orlayers and tissues, of the skin of the mammal that is damaged, injured,diseased, has an inflammatory reaction or condition, or requires, orcould benefit from, improvement.
 23. A composition of claim 22, whereinthe composition includes one or more flavorings.
 24. A composition ofclaim 22, wherein the active agent is hydrocortisone.
 25. A compositionof claim 23, wherein the active agent is hydrocortisone.
 26. Acomposition in a solid or semi-solid form for topical application to theskin of a mammal for repairing, improving or fully healing a skindisorder, disease, adverse condition, or other condition that requires,or could benefit from, improvement, or for causing the mammal's skin toexperience a reduction in pain, soreness or itchiness, or a combinationthereof, consisting of: (a) one or a plurality of active agents, whereinthe active agents are present in the composition in a combined amountranging from about 0.1 to about 5 weight percent; (b) Limnanthes Alba(Meadowfoam) Seed Oil, Butyrospermum Parkii (Shea Butter) Extract,wherein the Limnanthes Alba (Meadowfoam) Seed Oil, Butyrospermum Parkii(Shea Butter) Extract is present in the composition in an amount rangingfrom about 6 to about 25 weight percent; (c) Ricinus Communis (Castor)Seed Oil (and) Glycine Soja (Soybean) Germ Extract (and) Zea Mays (Corn)Starch (and) Silica, wherein the Ricinus Communis (Castor) Seed Oil(and) Glycine Soja (Soybean) Germ Extract (and) Zea Mays (Corn) Starch(and) Silica is present in the composition in an amount ranging fromabout 5 to about 39 weight percent; (d) C₁₂₋₁₅ Alkyl Benzoate, whereinthe C₁₂₋₁₅ Alkyl Benzoate is present in the composition in an amountranging from about 9 to about 25 weight percent; (e) bees wax, whereinthe bees wax is present in the composition in an amount ranging fromabout 6 to about 43 weight percent; (f) one or a plurality of plant oilsor plant seed oils, wherein the plant oils or plant seed oils arepresent in the composition in a combined amount ranging from about 0.1to about 37.5 weight percent; (g) one or a plurality of fatty alcohols,wherein the fatty alcohols are present in the composition in a combinedamount ranging from about 0.1 to about 25 weight percent; (h) one or aplurality of fats, wherein the fats are present in the composition in acombined amount ranging from about 0.1 to about 12 weight percent; and(i) optionally, one or a plurality of flavorings, wherein the flavoringsare present in the composition in a combined amount ranging from about 0to about 3.5 weight percent, wherein the composition is effective inrepairing, improving or fully healing skin of the mammal that isdamaged, injured, diseased, has an inflammatory reaction or condition,or requires, or could benefit from, improvement, or in causing themammal's skin to experience a reduction in pain, soreness or itchiness,or a combination thereof, and wherein the composition has an ability toact within one or more layers, tissues, or layers and tissues, of theskin of the mammal that is damaged, injured, diseased, has aninflammatory reaction or condition, or requires, or could benefit from,improvement.
 27. A composition of claim 26, wherein the compositionincludes one or more flavorings.
 28. A composition of claim 26, whereinthe active agent is hydrocortisone.
 29. A composition of claim 27,wherein the active agent is hydrocortisone.
 30. A composition in a solidor semi-solid form for topical application to the skin of a mammal forrepairing, improving or fully healing a skin disorder, disease, adversecondition, or other condition that requires, or could benefit from,improvement, or for causing the mammal's skin to experience a reductionin pain, soreness or itchiness, or a combination thereof, consisting of:(a) one or a plurality of active agents, wherein the active agents arepresent in the composition in a combined amount ranging from about 0.5to about 3 weight percent; (b) Limnanthes Alba (Meadowfoam) Seed Oil,Butyrospermum Parkii (Shea Butter) Extract, wherein the Limnanthes Alba(Meadowfoam) Seed Oil, Butyrospermum Parkii (Shea Butter) Extract ispresent in the composition in an amount ranging from about 6 to about 16weight percent; (c) Ricinus Communis (Castor) Seed Oil (and) GlycineSoja (Soybean) Germ Extract (and) Zea Mays (Corn) Starch (and) Silica,wherein the Ricinus Communis (Castor) Seed Oil (and) Glycine Soja(Soybean) Germ Extract (and) Zea Mays (Corn) Starch (and) Silica ispresent in the composition in an amount ranging from about 5 to about 15weight percent; (d) C₁₂₋₁₅ Alkyl Benzoate, wherein the C₁₂₋₁₅ AlkylBenzoate is present in the composition in an amount ranging from about10 to about 20 weight percent; (e) bees wax, wherein the bees wax ispresent in the composition in an amount ranging from about 6 to about 16weight percent; (f) one or a plurality of plant oils or plant seed oils,wherein the plant oils or plant seed oils are present in the compositionin a combined amount ranging from about 12 to about 37.5 weight percent;(g) one or a plurality of fatty alcohols, wherein the fatty alcohols arepresent in the composition in a combined amount ranging from about 15 toabout 25 weight percent; (h) one or a plurality of fats, wherein thefats are present in the composition in a combined amount ranging fromabout 2 to about 12 weight percent; and (i) optionally, one or aplurality of flavorings, wherein the flavorings are present in thecomposition in a combined amount ranging from about 0 to about 2.5weight percent, wherein the composition is effective in repairing,improving or fully healing skin of the mammal that is damaged, injured,diseased, has an inflammatory reaction or condition, or requires, orcould benefit from, improvement, or in causing the mammal's skin toexperience a reduction in pain, soreness or itchiness, or a combinationthereof, and wherein the composition has an ability to act within one ormore layers, tissues, or layers and tissues, of the skin of the mammalthat is damaged, injured, diseased, has an inflammatory reaction orcondition, or requires, or could benefit from, improvement.
 31. Acomposition of claim 30, wherein the composition includes one or moreflavorings.
 32. A composition of claim 30, wherein the active agent ishydrocortisone.
 33. A composition of claim 31, wherein the active agentis hydrocortisone.
 34. A composition in a solid or semi-solid form fortopical application to the skin of a mammal for repairing, improving orfully healing a skin disorder, disease, adverse condition, or othercondition that requires, or could benefit from, improvement, or forcausing the mammal's skin to experience a reduction in pain, soreness oritchiness, or a combination thereof, consisting of: (a) one or aplurality of active agents, wherein the active agents are present in thecomposition in a combined amount ranging from about 0.8 to about 2weight percent; (b) Limnanthes Alba (Meadowfoam) Seed Oil, ButyrospermumParkii (Shea Butter) Extract, wherein the Limnanthes Alba (Meadowfoam)Seed Oil, Butyrospermum Parkii (Shea Butter) Extract is present in thecomposition in an amount ranging from about 10 to about 12 weightpercent; (c) Ricinus Communis (Castor) Seed Oil (and) Glycine Soja(Soybean) Germ Extract (and) Zea Mays (Corn) Starch (and) Silica,wherein the Ricinus Communis (Castor) Seed Oil (and) Glycine Soja(Soybean) Germ Extract (and) Zea Mays (Corn) Starch (and) Silica ispresent in the composition in an amount ranging from about 9 to about 11weight percent; (d) C₁₂₋₁₅ Alkyl Benzoate, wherein the C₁₂₋₁₅ AlkylBenzoate is present in the composition in an amount ranging from about14 to about 16 weight percent; (e) bees wax, wherein the bees wax ispresent in the composition in an amount ranging from about 10 to about12 weight percent; (f) one or a plurality of plant oils or plant seedoils, wherein the plant oils or plant seed oils are present in thecomposition in a combined amount ranging from about 23.5 to about 26weight percent; (g) one or a plurality of fatty alcohols, wherein thefatty alcohols are present in the composition in a combined amountranging from about 19 to about 21 weight percent; (h) one or a pluralityof fats, wherein the fats are present in the composition in a combinedamount ranging from about 6 to about 8 weight percent; and (i)optionally, one or a plurality of flavorings, wherein the flavorings arepresent in the composition in a combined amount ranging from about 0.3to about 1.5 weight percent, wherein the composition is effective inrepairing, improving or fully healing skin of the mammal that isdamaged, injured, diseased, has an inflammatory reaction or condition,or requires, or could benefit from, improvement, or in causing themammal's skin to experience a reduction in pain, soreness or itchiness,or a combination thereof, and wherein the composition has an ability toact within one or more layers, tissues, or layers and tissues, of theskin of the mammal that is damaged, injured, diseased, has aninflammatory reaction or condition, or requires, or could benefit from,improvement.
 35. A composition of claim 34, wherein the compositionincludes one or more flavorings.
 36. A composition of claim 34, whereinthe active agent is hydrocortisone.
 37. A composition of claim 36,wherein the active agent is hydrocortisone.
 38. A composition of claim26, wherein the plant oil or plant seed oil is castor oil, the fattyalcohol is stearyl alcohol or the fat is cocoa butter, or anycombination thereof.
 39. A composition of claim 27, wherein the plantoil or plant seed oil is castor oil, the fatty alcohol is stearylalcohol or the fat is cocoa butter, or any combination thereof.
 40. Acomposition of claim 28, wherein the plant oil or plant seed oil iscastor oil, the fatty alcohol is stearyl alcohol or the fat is cocoabutter, or any combination thereof.
 41. A composition of claim 29,wherein the plant oil or plant seed oil is castor oil, the fatty alcoholis stearyl alcohol or the fat is cocoa butter, or any combinationthereof.
 42. A composition of claim 30, wherein the plant oil or plantseed oil is castor oil, the fatty alcohol is stearyl alcohol or the fatis cocoa butter, or any combination thereof.
 43. A composition of claim31, wherein the plant oil or plant seed oil is castor oil, the fattyalcohol is stearyl alcohol or the fat is cocoa butter, or anycombination thereof.
 44. A composition of claim 32, wherein the plantoil or plant seed oil is castor oil, the fatty alcohol is stearylalcohol or the fat is cocoa butter, or any combination thereof.
 45. Acomposition of claim 33, wherein the plant oil or plant seed oil iscastor oil, the fatty alcohol is stearyl alcohol or the fat is cocoabutter, or any combination thereof.
 46. A composition of claim 34,wherein the plant oil or plant seed oil is castor oil, the fatty alcoholis stearyl alcohol or the fat is cocoa butter, or any combinationthereof.
 47. A composition of claim 35, wherein the plant oil or plantseed oil is castor oil, the fatty alcohol is stearyl alcohol or the fatis cocoa butter, or any combination thereof.
 48. A composition of claim36, wherein the plant oil or plant seed oil is castor oil, the fattyalcohol is stearyl alcohol or the fat is cocoa butter, or anycombination thereof.
 49. A composition of claim 37, wherein the plantoil or plant seed oil is castor oil, the fatty alcohol is stearylalcohol or the fat is cocoa butter, or any combination thereof.
 50. Atopical base composition in a solid or semi-solid form for use as acarrier vehicle for one or a plurality of active agents, comprising (i)11.00 weight percent Limnanthes Alba (Meadowfoam) Seed Oil,Butyrospermum Parkii (Shea Butter) Extract, (ii) 10.00 weight percentRicinus Communis (Castor) Seed Oil (and) Glycine Soja (Soybean) GermExtract (and) Zea Mays (Corn) Starch (and) Silica, (iii) 15.00 weightpercent C₁₂₋₁₅ Alkyl Benzoate, (iv) 11.00 weight percent Bees Wax, (v)25.50 weight percent Castor Oil, (vi) 20.00 weight percent StearylAlcohol, (vii) 7.00 weight percent Cocoa Butter, and (viii) 0.50 weightpercent Flavoring (Vanilla), wherein the base composition has an abilityto function effectively as a topically-applied carrier vehicle for theactive agents, and wherein the base composition is effective inpromoting or causing a penetration of the active agents within one ormore layers, tissues, or layers and tissues, of skin of a mammal that isdamaged, injured, diseased or has an inflammatory reaction or condition.51. A composition in a solid or semi-solid form for topical applicationto the skin of a mammal for repairing, improving or fully healing a skindisorder, disease, adverse condition, or other condition that requires,or could benefit from, improvement, or for causing the mammal's skin toexperience a reduction in pain, soreness or itchiness, or a combinationthereof, comprising (i) 1.0 weight percent Hydrocortisone, (ii) 11.00weight percent Limnanthes Alba (Meadowfoam) Seed Oil, ButyrospermumParkii (Shea Butter) Extract, (iii) 10.00 weight percent RicinusCommunis (Castor) Seed Oil (and) Glycine Soja (Soybean) Germ Extract(and) Zea Mays (Corn) Starch (and) Silica, (iv) 15.00 weight percentC₁₂₋₁₅ Alkyl Benzoate, (v) 11.00 weight percent Bees Wax, (vi) 25.00weight percent Castor Oil, (vii) 20.00 weight percent Stearyl Alcohol,(viii) 7.00 weight percent Cocoa Butter, and (ix) 0.00 weight percentFlavoring (Vanilla), wherein the composition is effective in repairing,improving or fully healing skin of the mammal that is damaged, injured,diseased, has an inflammatory reaction or condition, or requires, orcould benefit from, improvement, or in causing the mammal's skin toexperience a reduction in pain, soreness or itchiness, or a combinationthereof, and wherein the composition has an ability to act within one ormore layers, tissues, or layers and tissues, of the skin of the mammalthat is damaged, injured, diseased, has an inflammatory reaction orcondition, or requires, or could benefit from, improvement.
 52. Acomposition of claim 21, claim 22, claim 23, claim 26, claim 27, claim30, claim 31, claim 34, claim 35, claim 38, claim 39, claim 42, claim43, claim 46, claim 47 or claim 51, wherein one of the active agents isselected from the group consisting of: clobetasol propionate 0.05%;betamethasone dipropionate 0.25%; halobetasol proprionate 0.05%;diflorasone diacetate 0.05%; fluocinonide 0.05%; halcinonide 0.05%;amcinonide 0.05%; desoximetasone 0.25%; triamcinolone acetonide; 0.5%;mometasone furoate 0.1%; fluticasone propionate 0.005%; betamethasonedipropionate 0.05%; fluocinolone acetonide 0.01-0.2%; hydrocortisonevalerate 0.2%; hydrocortisone butyrate 0.1%; flurandrenolide 0.05%;triamcinolone acetonide 0.1%; triamcinolone acetonide 0.1%; fluticasonepropionate 0.05%; desonide 0.05%; fluocinolone acetonide 0.025%;hydrocortisone valerate 0.2%; prednicarbate 0.05%; triamcinoloneacetonide 0.025%; fluocinolone acetonide 0.01%; desonide 0.05%;hydrocortisone 2.5%; hydrocortisone 1%; topical erythromycin; topicalmupirocin; topical retapamulin; topical bacitracin/polymyxin B; topicalbacitracin/neomycin/polymyxin B; topical sulfacetamide sodium/urea;natamycin; rimocidin; filipin; nystatin; amphotericin B; candicin;hamycin; miconazole; miconazole nitrate; ketoconazole; clotrimazole;econazole; bifonazole; butoconazole; fenticonazole; isoconazole;oxiconazole; sertaconazole; sulconazole; tioconazole; fluconazole;itraconazole; isavuconazole; ravuconazole; posaconazole; voriconazole;terconazole; abafungin; terbinafine; naftifine; butenafine;anidulafungin; caspofungin; micafungin; polygodial; ciclopirox;ciclopirox olamine; tolnaftate; undecylenic acid; flucytosine;5-fluorocytosine; griseofulvin; haloprogin; sodium bicarbonate;pimecrolimus 1% Cream; tacrolimus 0.1% ointment; clemastine;diphenhydramine; doxylamine; loratadine; desloratadine; fexofenadine;pheniramine; cetirizine; ebastine; promethazine; chlorpheniramine;levocetirizine; olopatadine; quetiapine; meclizine; dimenhydrinate;embramine; dimethindene; dexchlorpheniramine; vitamin C; cimetidine;famotidine; ranitidine; nizatidine; roxatidine; lafutidine; ciproxifan;clobenpropit; thioperamide; cromoglicate; nedocromil; a 132 adrenergicagonist; acetaminophen; diclofenac; diflunisal; etodolac; fenoprofen;flurbiprofen; ibuprofen; indomethacin; ketoprofen; ketorolac;meclofenamate; mefenamic acid; meloxicam; nabumetone; naproxen;oxaprozin; phenylbutazone; piroxicam; sulindac; tolmetin; celecoxib;buprenorphine; butorphanol; codeine; hydrocodone; hydromorphone;levorphanol; meperidine; methadone; morphine; nalbuphine; oxycodone;oxymorphone; pentazocine; propoxyphene; tramadol; tramadol andacetaminophen; butalbital, acetaminophen, and caffeine; butalbital,aspirin, and caffeine; butalbital, acetaminophen, caffeine, and codeine;hydrocodone and ibuprofen; pentazocine/naloxone; acetaminophen andcodeine; dihydrocodeine, acetaminophen, and caffeine; hydrocodone andacetaminophen; oxycodone and acetaminophen; pentazocine andacetaminophen; propoxyphene and acetaminophen; aspirin, caffeine anddihydrocodeine; aspirin and codeine; hydrocodone and aspirin; oxycodoneand aspirin; pentazocine and aspirin; propoxyphene, aspirin, andcaffeine; capsaicin; benzocaine; benzocaine/menthol; dibucaine;lidocaine; lidocaine/prilocaine; onabotulinumtoxinA; abobotulinumtoxinA;incobotulinumtoxinA; botulinum toxin type A; DEET(N,N-diethyl-m-toluamide); essential oil; icaridin; nepetalactone;citronella oil; permethrin; neem oil; bog myrtle;3-[N-Butyl-N-acetyl]-aminopropionic acid, ethyl ester; p-aminobenzoicacid; padimate O; phenylbenzimidazole sulfonic acid; cinoxate;dioxybenzone; oxybenzone; homosalate; menthyl anthranilate; octocrylene;octyl methoxycinnamate; octyl salicylate; sulisobenzone; trolaminesalicylate; avobenzone; ecamsule; titanium dioxide; zinc oxide;4-methylbenzylidene camphor; bisoctrizole; bis-ethylhexyloxyphenolmethoxyphenyl triazine; disodium phenyl dibenzimidazole tetrasulfonate;drometrizole trisiloxane; benzophenone-9; ethylhexyl triazone;diethylamino hydroxybenzoyl hexyl benzoate; iscotrizinol;polysilicone-15; and isopentenyl-4-methoxycinnamate.